FMZ · Class II · 21 CFR 880.5400

FDA Product Code FMZ: Incubator, Neonatal

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

86
Total
86
Cleared
136d
Avg days
1978
Since
86 devices
49–72 of 86
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 Sep 17, 1992
FIRST TOUCH/VILEDON NON-WOVEN FILTER
K915752
First Touch Disposables, Inc.
General Hospital · 269d
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 22, 1991
INCUBATOR 8000 IC
K913394
Dragerwerk AG
General Hospital · 115d
Cleared Nov 22, 1991
INCUBATOR 8000 SC
K914134
National Draeger, Inc.
General Hospital · 115d
Cleared Nov 13, 1991
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291
Air-Shields, Inc.
General Hospital · 112d
Cleared Nov 05, 1991
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
K912909
Air-Shields Vickers, Inc.
General Hospital · 126d
Cleared Oct 30, 1991
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
K912910
Air-Shields Vickers, Inc.
General Hospital · 120d
Cleared Sep 13, 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154
Ohmeda Medical
General Hospital · 63d
Cleared Mar 27, 1991
MP4, MP4SI, IT4 INCUBATORS
K901157
Mediprema
General Hospital · 379d
Cleared Oct 15, 1990
MODEL C286 ISOLETTE INFANT INCUBATOR
K903378
Air-Shields Vickers, Inc.
General Hospital · 77d
Cleared Aug 02, 1990
INCUBATOR 8000
K900752
Dragerwerk AG
General Hospital · 167d
Cleared Jun 22, 1990
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585
Ohmeda Medical
General Hospital · 79d
Cleared May 02, 1990
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
K900735
Preemicare Corp.
General Hospital · 75d
Cleared Dec 07, 1989
K-1 INFANT TRANSPORT SYSTEM
K895550
K-1 Medical Products, Inc.
General Hospital · 85d
Cleared Dec 07, 1989
NEONATAL INCUBATOR (ACCESSORY)
K895782
Air-Shields Vickers, Inc.
General Hospital · 71d
Cleared Jun 16, 1989
ADEL - MODEL 986 INFANT WARMER
K890476
Adel Medical , Ltd.
General Hospital · 136d
Cleared Dec 08, 1988
PREEMICARE MODEL D1-X1, SERIES 3000
K881476
Preemicare Corp.
General Hospital · 245d
Cleared Nov 14, 1988
C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
K884086
Air-Shields Vickers, Inc.
General Hospital · 48d
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