FMZ · Class II · 21 CFR 880.5400

FDA Product Code FMZ: Incubator, Neonatal

Leading manufacturers include Ohmeda Medical, Air-Shields, Inc. and Vickers America Medical Corp..

86
Total
86
Cleared
136d
Avg days
1978
Since
86 devices
25–48 of 86
Cleared May 29, 1998
BABYTHERM 8000 LDR
K980886
Draeger Medical, Inc.
General Hospital · 81d
Cleared Feb 12, 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349
Ohmeda Medical
General Hospital · 85d
Cleared Apr 25, 1997
DRAGER INCUBATOR 8000 IC
K954204
Drager, Inc.
General Hospital · 597d
Cleared Sep 20, 1996
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806
Ohmeda Medical
General Hospital · 64d
Cleared Jul 30, 1996
ISOLETTE INFANT INCUBATOR
K960980
Air-Shields, Inc.
General Hospital · 141d
Cleared Sep 29, 1994
OHIO CARE PLUS INCUBATOR
K943360
Ohmeda Medical
General Hospital · 79d
Cleared Jun 23, 1994
C450/C400 INFANT INCUBATORS
K940975
Air-Shields, Inc.
General Hospital · 112d
Cleared Feb 05, 1993
ISOLETTE INCUBATOR HUMIDITY METER
K924170
Air-Shields, Inc.
General Hospital · 170d
Cleared Sep 21, 1992
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000
S & W Medico Teknik
General Hospital · 516d
Cleared Mar 13, 1992
MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR
K914864
Air-Shields, Inc.
General Hospital · 136d
Cleared Dec 18, 1991
OHIO CARE PLUS INCUBATOR
K914487
Ohmeda Medical
General Hospital · 71d
Cleared Nov 13, 1991
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291
Air-Shields, Inc.
General Hospital · 112d
Cleared Sep 13, 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154
Ohmeda Medical
General Hospital · 63d
Cleared Jun 22, 1990
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585
Ohmeda Medical
General Hospital · 79d
Cleared Jun 10, 1987
AMEDA AMECARE(R) NEONATAL INCUBATOR
K870222
Hollister, Inc.
General Hospital · 140d
Cleared Jun 10, 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223
Hollister, Inc.
General Hospital · 140d
Cleared Jun 05, 1987
OHIO(R) CARE PLUS INCUBATOR
K871399
Ohmeda Medical
General Hospital · 59d
Cleared Oct 18, 1982
C-200 INFANT INCUBATOR
K822656
Narco Scientific
General Hospital · 45d
Cleared Jul 28, 1982
C-300 INFANT INCUBATOR
K821896
Narco Scientific
General Hospital · 30d
Cleared Jan 28, 1982
OXYGENAIRE NURING INCUBATOR
K813239
Vickers America Medical Corp.
General Hospital · 72d
Cleared Jan 22, 1982
NEOCARE BABY-CONTROLLED INCUBATOR
K813238
Vickers America Medical Corp.
General Hospital · 66d
Cleared Apr 29, 1981
NEOCARE TEMPERATURE MONITOR
K810792
Vickers America Medical Corp.
General Hospital · 37d
Cleared Mar 11, 1981
140 NEOCARE AIR CONTROLLED INCUBATOR
K810067
Vickers America Medical Corp.
General Hospital · 57d
Cleared Nov 12, 1980
OHIO IC INCUBATOR
K802639
Ohio Medical Products
General Hospital · 20d