FDA 510(k) Applications for Medical Device Product Code "BZE"
(Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)

FDA 510(k) Number Applicant Device Name Decision Date
K881137 ADVANCED RESEARCH TECHNOLOGIES, INC. VAPOR-PHASE HEATED WIRE CONTROLLER 04/27/1988
K993833 ALLEGIANCE HEALTHCARE CORP. AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS 12/10/1999
K000697 ALLEGIANCE HEALTHCARE CORP. MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS 03/30/2000
K851245 APPLINC ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY 05/15/1985
K842597 APPLINC RESPIRATORY GAS HUMIDIFIER 01/16/1985
K844005 ARMOUR PHARMACEUTICAL CO. ARM-A-VIAL LV HEATER-BREATHING SYS 11/08/1984
K915226 BAXTER HEALTHCARE CORP. ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT 01/12/1993
K894654 BIRD PRODUCTS CORP. FLEXHTR-1 08/01/1990
K780630 C.R. BARD, INC. CONTROLLER, SERVO, INSPIRON 05/31/1978
K880769 DRYDEN CORP. BREATHING CIRCUIT W/HEATED WIRE 08/24/1988
K103767 FISHER & PAYKEL HEALTHCARE LTD. DUAL HEATED INFANT VREATHING CIROUITS 04/16/2012
K122432 FISHER & PAYKEL HEALTHCARE, LTD. ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS 12/06/2012
K034026 FISHER & PAYKEL HEALTHCARE, LTD. RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS 01/12/2005
K150900 FLEXICARE MEDICAL LTD. Flexicare Heated Wire Breathing Systems 5/15/2015
K761295 HARRIS-LAKE, INC. RESP. AIR TEMP. CONTROL & HAZARD MON. 12/30/1976
K781530 HEALTHDYNE, INC. TEMPERATURE CONTROLLER MODEL 17000 11/14/1978
K914994 HPD MEDICAL, INC. HPD HEATER BASES 02/12/1993
K860941 INTEC MEDICAL, INC. DISPOSABLE HEATED WIRE LOOPS 48" AND 72" 04/02/1986
K092129 INTERSURGICAL, INC. INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 05/18/2010
K881231 INTERTECH RESOURCES, INC. DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT 07/01/1988
K873179 LIFE DESIGN SYSTEMS, INC. HEATER WIRE BREATHING CIRCUIT 03/31/1988
K962220 MARQUEST MEDICAL PRODUCTS, INC. HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER 01/14/1997
K770984 MISTOGEN EQUIPMENT CO. TA-2 TEMPERATURE ALARM 07/05/1977
K801101 NARCO MCKESSON CO. ANALOR FOUR-ORAL SURGERY MODEL 06/17/1980
K952267 NOVA-VENTRX CRITERION, CRITERION I.V., MODIFIED 12/02/1997
K100104 PLASTIFLEX GROUP NV HYBERNITE RAINOUT CONTROL SYSTEM 04/14/2010
K894936 PROTOLOGIC, INC. PROTOLOGIC MODEL SER-1 01/22/1990
K881625 RESPIRATORY CARE, INC. CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL 06/21/1988
K110398 RESPIRONICS, INC. RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS 06/01/2011
K881451 SIMPLEX MEDICAL CORP. SIMPLEX UNIVERSAL HEATED TUBING SLEEVE 06/10/1988
K821735 TROPIC AIR TROPIC AIR HEAT-ECHANGER BREATHING AID 09/07/1982


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact