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510k Database
Manufacturers
US
Drager, Inc.
Medical Device Manufacturer
·
US , Pittsburgh , PA
Drager, Inc. - FDA 510(k) Cleared Devices
20 submissions
·
15 cleared
·
Since 1991
20
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Drager, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198
·
FMT
General Hospital
·
186d
Cleared
Apr 25, 1997
DRAGER INCUBATOR 8000 IC
K954204
·
FMZ
General Hospital
·
597d
Cleared
Feb 09, 1996
DRAGER INFANT RADIANT WARMERN RH600
K953489
·
FMT
General Hospital
·
199d
Cleared
Dec 01, 1995
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611
·
LBI
General Hospital
·
58d
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