BZE · Class II · 21 CFR 868.5270

FDA Product Code BZE: Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

Leading manufacturers include Fisher &Paykel Healthcare , Ltd., Allegiance Healthcare Corp. and Plastiflex Group NV.

46
Total
46
Cleared
193d
Avg days
1976
Since
46 devices
25–46 of 46
Cleared Dec 02, 1997
CRITERION, CRITERION I.V., MODIFIED
K952267
Nova-Ventrx
Anesthesiology · 932d
Cleared Jan 14, 1997
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220
Marquest Medical Products, Inc.
Anesthesiology · 218d
Cleared Feb 12, 1993
HPD HEATER BASES
K914994
Hpd Medical, Inc.
Anesthesiology · 463d
Cleared Jan 12, 1993
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226
Baxter Healthcare Corp
Anesthesiology · 419d
Cleared Aug 01, 1990
FLEXHTR-1
K894654
Bird Products Corp.
Anesthesiology · 373d
Cleared Jan 22, 1990
PROTOLOGIC MODEL SER-1
K894936
Protologic, Inc.
Anesthesiology · 172d
Cleared Aug 24, 1988
BREATHING CIRCUIT W/HEATED WIRE
K880769
Dryden Corp.
Anesthesiology · 177d
Cleared Jul 01, 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231
Intertech Resources, Inc.
Anesthesiology · 101d
Cleared Jun 21, 1988
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
K881625
Respiratory Care, Inc.
Anesthesiology · 70d
Cleared Jun 10, 1988
SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
K881451
Simplex Medical Corp.
Anesthesiology · 65d
Cleared Apr 27, 1988
VAPOR-PHASE HEATED WIRE CONTROLLER
K881137
Advanced Research Technologies, Inc.
Anesthesiology · 42d
Cleared Mar 31, 1988
HEATER WIRE BREATHING CIRCUIT
K873179
Life Design Systems, Inc.
Anesthesiology · 232d
Cleared Apr 02, 1986
DISPOSABLE HEATED WIRE LOOPS 48 AND 72
K860941
Intec Medical, Inc.
Anesthesiology · 21d
Cleared May 15, 1985
ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
K851245
Applinc
Anesthesiology · 49d
Cleared Jan 16, 1985
RESPIRATORY GAS HUMIDIFIER
K842597
Applinc
Anesthesiology · 197d
Cleared Nov 08, 1984
ARM-A-VIAL LV HEATER-BREATHING SYS
K844005
Armour Pharmaceutical Co.
Anesthesiology · 27d
Cleared Sep 07, 1982
TROPIC AIR HEAT-ECHANGER BREATHING AID
K821735
Tropic Air
Anesthesiology · 85d
Cleared Jun 17, 1980
ANALOR FOUR-ORAL SURGERY MODEL
K801101
Narco Mckesson Co.
Anesthesiology · 39d
Cleared Nov 14, 1978
TEMPERATURE CONTROLLER MODEL 17000
K781530
Healthdyne, Inc.
Anesthesiology · 69d
Cleared May 31, 1978
CONTROLLER, SERVO, INSPIRON
K780630
C.R. Bard, Inc.
Anesthesiology · 44d
Cleared Jul 05, 1977
TA-2 TEMPERATURE ALARM
K770984
Mistogen Equipment Co.
Anesthesiology · 35d
Cleared Dec 30, 1976
RESP. AIR TEMP. CONTROL & HAZARD MON.
K761295
Harris-Lake, Inc.
Anesthesiology · 9d