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510(k) K951126

DRAGER MEDICAL AIR COMPRESSOR by Drager, Inc. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
March 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
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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  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)