FDA 510(k) Applications for Medical Device Product Code "BYD"
(Condenser, Heat And Moisture (Artificial Nose))

FDA 510(k) Number Applicant Device Name Decision Date
K854012 AMERICAN PHARMASEAL DIV. AHSC AMERICAN PHARMASEAL HUMIDAIR CONDENSER 12/03/1985
K945359 ARTEMA MEDICAL AB AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H 02/21/1995
K912333 ARTEMA MEDICAL AB ARTEMA AQUA+ 07/26/1991
K912336 ARTEMA MEDICAL AB ARTEMA AQUA+ FLEX 07/26/1991
K912335 ARTEMA MEDICAL AB ARTEMA AQUA+ N 07/26/1991
K912334 ARTEMA MEDICAL AB ARTEMA AQUA+ T & TS 07/26/1991
K933597 ARTHRO-MEDIC, INC. AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH 11/01/1993
K934190 BIRD LIFE DESIGN HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION 11/24/1993
K923910 CONCORD/PORTEX HEAT MOISTURE CONDENSER 01/26/1993
K941813 CYBERMEDIC, INC. VENSHIELD 05/03/1994
K953540 EDENTEC CORP. EEE 08/25/1995
K954194 ENGSTROM MEDICAL DISPOSABLE HME/FILTER 10/20/1995
K904193 FLOCARE MEDICAL FLOCARE 11/29/1990
K912700 FLOCARE MEDICAL FLOCARE DRY CAS SAMPLING PORT MODELS 09/11/1991
K912699 FLOCARE MEDICAL FLOCARE LF-A 09/11/1991
K902501 FLOCARE MEDICAL FLOCARE N 07/02/1990
K864095 GAMBRO, INC. ENGSTROM EDITH MODELS 500,1000,1500 & 1500F 02/20/1987
K881644 GIBECK RESPIRATION HUMID-VENT 2 S 06/10/1988
K881656 GIBECK RESPIRATION HUMID-VENT 2 S FLEX 06/16/1988
K881657 GIBECK RESPIRATION HUMID-VENT FILTER 06/24/1988
K873768 GIBECK RESPIRATION HUMID-VENT(R) 2 PORT 11/24/1987
K873767 GIBECK RESPIRATION HUMID-VENT(R) MINI 11/06/1987
K872153 GIBECK RESPIRATION STOM-VENT 08/03/1987
K952750 GIBECK, INC. HUMID-VENT 1 07/20/1995
K953491 GIBECK, INC. HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE 08/25/1995
K952844 GIBECK, INC. HUMID-VENT 2 07/20/1995
K953544 GIBECK, INC. HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT 08/25/1995
K952084 GIBECK, INC. HUMID-VENT FILTER PEDI 06/12/1995
K951856 GIBECK, INC. HUMID-VENT MICRO 06/07/1995
K952845 GIBECK, INC. HUMID-VENT TRACH-VENT 07/25/1995
K915786 HELIX MEDICAL, INC. BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. 06/30/1992
K953619 HOSPITAK, INC. WARM N WET HME W/LUER ADAPTER 08/25/1995
K953620 HOSPITAK, INC. WARM N WET HMEF W/LUER ADAPTER 08/25/1995
K941436 ICOR AB AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF 06/08/1994
K881308 ICOR AB BREATH-EASY 05/17/1988
K952823 ICOR AB FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE 07/13/1995
K925622 ICOR AB FHB, FHB-T, FHBFLEX, FHBFLEX-T 05/26/1993
K900150 ICOR AB HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE 01/25/1990
K941987 ICOR AB HEAT AND MOISTURE EXCHANGERS AND FILTERS 08/15/1994
K904338 ICOR AB ICOR HCH 4, ICOR HCH 7 12/04/1990
K872371 ICOR AB ICOR NEONATAL HCH 09/04/1987
K953507 ICOR AB TYPE 1 & 2 (HUMIDAIR I & II) 09/07/1995
K955008 INTERTECH RESOURCES, INC. HEAT & MOISTURE EXCHANGER 01/30/1996
K953580 INTERTECH RESOURCES, INC. HEAT MOISTURE EXCHANGER 09/15/1995
K935036 INTERTECH RESOURCES, INC. HEPA FILTERED HEAT AND MOISTURE EXCHANGER 01/25/1994
K903519 INTERTECH RESOURCES, INC. INTERTECH(TM) HEAT AND MOISTURE EXCHANGER 12/13/1990
K862020 INTERTECH/OHIO HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER 06/30/1986
K934441 KING SYSTEMS CORP. KING SYSTEMS HME 12/02/1993
K885313 LIFE DESIGN SYSTEMS, INC. HUMIDI-FLEX TM 10/11/1989
K821365 LKB INSTRUMENTS, INC. ENGSTOM EDITH 06/29/1982
K840399 MALLINCKRODT CRITICAL CARE FOAM NOSE 03/16/1984
K840398 MALLINCKRODT CRITICAL CARE INLINE FOAM NOSE 03/16/1984
K952036 MALLINCKRODT MEDICAL FLEXLIFE 06/08/1995
K942794 MALLINCKRODT MEDICAL HYGROLIFE 08/22/1994
K941585 MALLINCKRODT MEDICAL HYGROSTER 04/19/1994
K941535 MALLINCKRODT MEDICAL TRACHEOLIFE 04/15/1994
K922946 MALLINCKRODT MEDICAL VAPORTEMP HEAT AND MOISTURE EXCHANGER 03/08/1993
K946209 MED-PLASTICS INTL., INC. DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME 06/08/1995
K944194 MED-TEK INNOVATIONS, INC. DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME 09/13/1994
K943915 MEDICOMP, INC. HEAT AND MOISTURE EXCHANGER FILTER (HME) 10/14/1994
K893875 MEGA-TECH INTL., INC. FLOCARE 08/11/1989
K834292 PALL BIOMEDICAL PRODUCTS CO. PALL HEAT MOISTURE EXCHANGING FILTER 04/04/1984
K903058 PHARMA SYSTEMS, INC. BACT-HME (TM) 11/09/1990
K903057 PHARMA SYSTEMS, INC. FREEVENT (TM) 11/20/1990
K903054 PHARMA SYSTEMS, INC. HME-10 (TM) 10/31/1990
K874597 PORTEX, INC. THERMOVENT 600, 1200, T, 02 01/19/1988
K790681 SIEMENS CORP. SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150 04/13/1979
K844040 SIEMENS ELEMA AB SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB 10/25/1984
K852601 SIEMENS ELEMA AB SERVO HUMIDIFIER 153 07/08/1985
K945657 TEC II MEDICAL, INC. DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER 12/07/1994
K923865 VITAL SIGNS, INC. 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID 02/01/1993
K914336 VITAL SIGNS, INC. BREATHE EASY 03/25/1992
K950447 VITAL SIGNS, INC. FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT 02/21/1995


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