Medical Device Manufacturer · US , Pittsburgh , PA

Drager, Inc. - FDA 510(k) Cleared Devices

20 submissions · 15 cleared · Since 1991

Recent clearances: ATC OPTION FOR EVITA 2 DURA AND EVITA 4, DRAGER OXYLOG 2000, NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900

Total

Cleared

Denied

Drager, Inc. has 15 FDA 510(k) cleared anesthesiology devices. Based in Pittsburgh, US.

Historical record: 15 cleared submissions from 1991 to 1999.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Drager, Inc. is one of 5537 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Drager, Inc.

20 devices

1-12 of 20

Cleared Aug 24, 1999

ATC OPTION FOR EVITA 2 DURA AND EVITA 4

NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900

K983219 · CBK

Anesthesiology · 84d

Cleared Oct 29, 1998

MEDICAL AIR COMPRESSOR, MODEL # 8413419

Anesthesiology · 197d

Cleared Jun 17, 1998

BABYLOG 8000 PLUS

K974176 · CBK

Anesthesiology · 223d

Cleared Oct 03, 1997

BABYTHERM 8004 BABYTHERM 8010

K971198 · FMT

General Hospital · 186d

Cleared Aug 26, 1997

EVITA 2 DURA

K970165 · CBK

Anesthesiology · 222d

Cleared Apr 25, 1997

DRAGER INCUBATOR 8000 IC

K954204 · FMZ

General Hospital · 597d

Cleared Dec 13, 1996

EVITA 4

K961687 · CBK

Anesthesiology · 226d

Cleared Nov 05, 1996

OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS

K950853 · CBK

Anesthesiology · 617d

Cleared Sep 16, 1996

DRAGER MICRO VENT

K953238 · CBK

Anesthesiology · 433d

Drager, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Drager, Inc.

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