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Drager, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4August 24, 1999
K984577DRAGER OXYLOG 2000January 22, 1999
K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900December 7, 1998
K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419October 29, 1998
K980642EVITA 4 (8411900)September 4, 1998
K974176BABYLOG 8000 PLUSJune 17, 1998
K971198BABYTHERM 8004 BABYTHERM 8010October 3, 1997
K970165EVITA 2 DURAAugust 26, 1997
K954204DRAGER INCUBATOR 8000 ICApril 25, 1997
K961687EVITA 4December 13, 1996
K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORSNovember 5, 1996
K953238DRAGER MICRO VENTSeptember 16, 1996
K953489DRAGER INFANT RADIANT WARMERN RH600February 9, 1996
K954611DRAGER PT4000 PHOTOTHERAPY SYSTEMDecember 1, 1995
K943531OXYLOG 2000August 25, 1995
K945467BABYTHERM 8000 WBApril 28, 1995
K951126DRAGER MEDICAL AIR COMPRESSORMarch 24, 1995
K926292BABYLOG 8000 INFANT VENTILATORApril 19, 1994
K924930EVITAJanuary 10, 1994
K903089BABYLOG 8000 INFANT VENTILATORJune 10, 1991