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510(k) K954204

DRAGER INCUBATOR 8000 IC by Drager, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1997
Date Received
September 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

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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)
  • K961687 — EVITA 4 (December 13, 1996)
  • K950853 — OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS (November 5, 1996)

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