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 Respironics, Inc..

46
Total
46
Cleared
193d
Avg days
1976
Since
46 devices
25–46 of 46
Cleared Jan 14, 1997
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220
Marquest Medical Products, Inc.
Anesthesiology · 218d
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 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 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 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