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510(k) K040220

MEDICAL AIR COMPRESSOR by eVent Medical, Ltd. — Product Code BTI

K040220 is an FDA 510(k) premarket notification submitted by eVent Medical, Ltd. for the device "MEDICAL AIR COMPRESSOR". The FDA issued a decision of Substantially Equivalent on June 9, 2004. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. eVent Medical, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2004
Date Received
February 2, 2004
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 eVent Medical, Ltd.

  • K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7I (October 29, 2013)
  • K113743 — EVOLUTION 3E VENTILATOR (December 18, 2012)
  • K072590 — INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM A (January 4, 2008)
  • K051550 — INSPIRATION VENTILATOR SYSTEM (July 12, 2005)
  • K030341 — MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (January 16, 2004)
  • K021112 — INSPIRATION VENTILATOR SYSTEM (November 22, 2002)

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)
  • K031686 — AEROMIST LT, MODEL HCS15004 (January 21, 2004)

FDA data resources