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510(k) K982789

MEDICAL AIR COMPRESSOR, MODEL # 8413419 by Drager, Inc. — Product Code BTI

K982789 is an FDA 510(k) premarket notification submitted by Drager, Inc. for the device "MEDICAL AIR COMPRESSOR, MODEL # 8413419". The FDA issued a decision of Substantially Equivalent on October 29, 1998. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Drager, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1998
Date Received
August 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Drager, Inc.

  • K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 4 (August 24, 1999)
  • K984577 — DRAGER OXYLOG 2000 (January 22, 1999)
  • K983219 — NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 (December 7, 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)
  • K950853 — OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS (November 5, 1996)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources