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510(k) K903089

BABYLOG 8000 INFANT VENTILATOR by Drager, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
July 13, 1990
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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  • K983219 — NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 (December 7, 1998)
  • 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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