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
73–86 of 86
Cleared Apr 30, 1984
AMETHERM
K840526
Egnell, Inc.
General Hospital · 83d
Cleared Sep 12, 1983
OHIO TEMPERATURE SIMULATOR
K832418
Airco/Ohio Medical Products
General Hospital · 52d
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
Cleared Nov 12, 1980
OHIO GC INCUBATOR
K802640
Ohio Medical Products
General Hospital · 20d
Cleared Sep 26, 1980
ISOLETTE INCUBATOR C-100
K802126
Narco Air-Shields
General Hospital · 22d
Cleared Jul 28, 1980
THERMA-SHIELD
K801461
Olympic Medical Corp.
General Hospital · 34d
Cleared Dec 07, 1978
ISOLETTE INCUBATOR
K781876
Air-Shields, Inc.
General Hospital · 35d
Cleared Apr 19, 1978
INFANT INCUBATOR
K780472
Air-Shields, Inc.
General Hospital · 26d