FDA 510(k) Applications for Medical Device Product Code "BZO"
(Set, Tubing And Support, Ventilator (W Harness))

FDA 510(k) Number Applicant Device Name Decision Date
K820131 3M COMPANY 3M VOLUME VENTIATOR CIRCUIT 01/28/1982
K833459 AIRCO/OHIO MEDICAL PRODUCTS COAXIAL VOL. VENTILATOR CIRCUIT 01/10/1984
K791856 AIRLIFE, INC. "Y" & ELBOW W/WO PORTS 09/26/1979
K792047 AIRLIFE, INC. CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT, 10/30/1979
K791761 AIRLIFE, INC. CIRCUIT, BREATHING W/WO NEBULIZER 10/26/1979
K792030 AIRLIFE, INC. TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT 10/30/1979
K834570 AIRLIFE, INC. VOLUME VENTILATOR CIRCUIT W/WATER TRAP 03/05/1984
K841378 AIRMED CORP. VENT-WELL VENTILATOR TUBING 05/02/1984
K874559 AIROFLEX MEDICAL, INC. BABYFLEX PATIENT CIRCUIT 12/21/1987
K863910 ARTEC ENVIRONMENTAL MONITORING DIVISION RAINCOAT 10/20/1986
K842389 AVATRON, INC. AVATRON DISPOSABLE I.P.P.B. CIRUCIT 06/26/1984
K842778 AVATRON, INC. AVATRON UNIVERSAL ADULT VOL. VENTILATOR 07/26/1984
K880637 BAXTER HEALTHCARE CORP. BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES 04/11/1988
K823479 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MODUFLEX NEONATAL VENTILATOR SET 12/15/1982
K850703 BIVONA MEDICAL TECHNOLOGIES SAF T FLO VENTILATOR TUBING 03/25/1985
K770581 C.D. & F. CORP. CORRUGATED TUBING, 770 & 771 04/19/1977
K821064 C.R. BARD, INC. INSPIRON NEONATAL VENTILATOR CIRCUIT 05/03/1982
K932119 CLEVELAND TUBING, INC. CLEVELAND TUBING, INC. VENTILATOR HOSES 06/23/1993
K834569 CRYO CORP. VENTILATORY FREQUENCY MONITOR 03/30/1984
K830923 CYGNUS RESEARCH CORP. TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA 05/03/1983
K830922 CYGNUS RESEARCH CORP. TEMP-CHECK ADAPTOR, TEE-CONFIGURATION 05/02/1983
K830921 CYGNUS RESEARCH CORP. TEMP-CHECK ADAPTOR, Y-CONFIGURATION 05/02/1983
K860879 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DISPOSABLE VENTILATOR CIRCUITS 03/20/1986
K860880 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. VENTILATOR CIRCUITS (VARIOUS TYPES) 03/20/1986
K841722 DRYDEN CORP. MASS SPECTROMETER INTERFACE 05/14/1984
K873927 DRYDEN CORP. REUSEABLE BREATHING TUBES 10/20/1987
K841637 DRYDEN CORP. THREE PORT SENSOR MANIFOLD 05/02/1984
K903404 FLOCARE MEDICAL FLOCARE F 09/25/1990
K945740 HAMILTON MEDICAL, INC. INFANT FLOW SYSTEM 03/23/1995
K791469 HOSPITAK, INC. MANIFOLD/NEBULIZER BREATHING PRODUCTS 08/28/1979
K832681 HUDSON OXYGEN THERAPY SALES CO. UNIVERSAL VOL. VENTILATOR 72" #1626 09/26/1983
K812774 HUDSON OXYGEN THERAPY SALES CO. VENTILATOR CIRCUIT 10/23/1981
K903083 HUDSON RESPIRATORY CARE, INC. NEONATAL VENTILATOR CIRCUIT 12/27/1990
K812773 IDEAL MEDICAL, INC. BENNETT VOLUME VENTILATOR CIRCUIT 10/23/1981
K843036 INFRASONICS CORP. PATIENT BREATHING CIRCUIT 08/15/1984
K934753 INFRASONICS CORP. STAR BREATHING CIRCUITS 10/27/1993
K770354 INHAL-O-TECH MEDICAL PLASTIC TUBING, AEROSAL, DISPOSABLE 03/16/1977
K820128 INHALATION THERAPY EQUIPMENT, CO. UNI-SET 03/23/1982
K772069 INSPIRON CORP. VOL. VENTILATOR SETUP W/OUT NEBULIZER 11/15/1977
K823481 INSTRUMENTATION INDUSTRIES, INC. BE #16 - MANIFOLD 12/22/1982
K823271 INTEC MEDICAL, INC. DISPOSABLE ADULT VO. VENTILATOR CIRCUIT 12/22/1982
K813384 INTEC. DISPOSABLE NEONATAL VENTILATION CIRCUIT 01/07/1982
K922479 INTERTECH RESOURCES, INC. DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED 10/30/1992
K911328 INTERTECH RESOURCES, INC. UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION 08/15/1991
K863033 INTERTECH/OHIO PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS 08/20/1986
K884525 INTERTECH/OHIO PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT 12/16/1988
K801087 ISOTHERMAL SYSTEMS, INC. NEONATAL BREATHING CIRCUIT SYSTEM 05/23/1980
K860659 LIFE DESIGN SYSTEMS, INC. END TIDAL CO2 SAMPLING CIRCUIT 04/17/1986
K890011 LIFE DESIGN SYSTEMS, INC. OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING 03/20/1989
K850151 LIFE PRODUCTS, INC. L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT 07/19/1985
K844290 LIFE PRODUCTS, INC. L100D PATIENT CIRCUIT DUAL LINE 01/10/1985
K932563 LIFE SHIELD HEALTHCARE PRODUCTS, INC. VENTILATOR HOSES 07/16/1993
K932560 LIFE SHIELD HEALTHCARE PRODUCTS, INC. VOLUME VENTILATORS 07/22/1993
K801859 LIFECARE SERVICES, INC. CAM-10 RESPIRATORY HOSE ASSEMBLIES 09/09/1980
K880959 LIFEGUARD MEDICAL PRODUCTS, INC. LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY 04/14/1988
K942569 MED-PLASTICS INTL., INC. VENTILATOR HOSE 06/10/1994
K942572 MED-PLASTICS INTL., INC. VOLUME VENTILATOR 06/10/1994
K850600 NOVA-VENTRX CO-AX VENTILATOR CIRCUIT 05/02/1985
K893760 NOVA-VENTRX CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 08/10/1989
K863756 NOVA-VENTRX MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT 11/13/1986
K812737 NOVA-VENTRX RAIN-X 10/23/1981
K903055 PHARMA SYSTEMS, INC. EXTENDED LIFE CIRCUITS 11/09/1990
K932712 PRECISION MED PRODUCTS, LTD. PRECISION MED PRODUCTS LTD VOLUME VENTILATORS 07/22/1993
K932706 PRECISION MED PRODUCTS, LTD. PRECISION MED PRODUCTS LTD. VENTILATOR HOSE 07/23/1993
K952011 PRIMA, INC. PRIMA BREATHING BAGS 05/22/1995
K952012 PRIMA, INC. PRIMA CUSTOM ANESTESIA CIRCUIT 05/22/1995
K952010 PRIMA, INC. PRIMA VENTILATOR HOSES 05/22/1995
K952022 PRIMA, INC. PRIMA VOLUMN VENTILATORSS 05/22/1995
K944531 PRIMA, INC. PRIMA, INC. CORRUGATED TUBING 12/02/1994
K873900 PURITAN BENNETT CORP. PORTABLE VENTILATOR PATIENT CIRCUIT 10/30/1987
K935582 PURITAS HEALTH CARE, INC. TUBE, INHALER OXYGEN 01/14/1994
K792268 RESPIRATORY CARE, INC. "CIRCAPAK" 11/27/1979
K861286 RESPIRATORY SUPPORT PRODUCTS, INC. GAS SAMPLING KIT 04/11/1986
K921510 RESPIRATORY SUPPORT PRODUCTS, INC. GAS SAMPLING KIT MODIFICATION 06/11/1992
K895853 SECHRIST INDUSTRIES, INC. SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT 12/22/1989
K791060 SHERWOOD MEDICAL CO. RAIN-X 06/15/1979
K841657 SIEMENS ELEMA AB PATIENT TUBING HYTREL SIEMENS-ELEMA 05/23/1984
K770593 SURGICOT, INC. CORRUGATED TUBING #770 & 771 04/19/1977
K882341 THAYER MEDICAL CORP. QUICK CONNECT T ADAPTOR 07/18/1988
K823287 THORATEC LABORATORIES CORP. RESPIRATORY CIRCUIT ADAPTOR 12/09/1982
K760993 TIMETER INSTRUMENT CORP. MECK/MILLER VENTILATION TUBE HARNESS 12/09/1976
K810341 TODD INDUSTRIES, INC. LIFELINE IPPB SET-UP 03/17/1981
K813155 TRAVENOL LABORATORIES, S.A. PEDIATRIC VENTILATOR CIRCUIT 2C7131 12/09/1981
K953784 UNICOR, INC. UNICOR, INC. CORRUGATED TUBING 09/19/1995
K953785 UNICOR, INC. UNICOR, INC. VENTILATOR HOSES 09/18/1995
K890822 VENTLAB CORP. CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) 05/05/1989
K896439 VENTLAB CORP. TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE 01/09/1990
K791034 VITAL SIGNS, INC. PIGGYBACK BREATHING CIRCUIT 06/15/1979


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