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510(k) K943531

OXYLOG 2000 by Drager, Inc. — Product Code CBK

Clearance Details

Decision
ST ()
Decision Date
August 25, 1995
Date Received
July 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Drager, Inc.

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  • K982789 — MEDICAL AIR COMPRESSOR, MODEL # 8413419 (October 29, 1998)
  • K980642 — EVITA 4 (8411900) (September 4, 1998)
  • K974176 — BABYLOG 8000 PLUS (June 17, 1998)
  • K971198 — BABYTHERM 8004 BABYTHERM 8010 (October 3, 1997)
  • K970165 — EVITA 2 DURA (August 26, 1997)
  • K954204 — DRAGER INCUBATOR 8000 IC (April 25, 1997)
  • K961687 — EVITA 4 (December 13, 1996)

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