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510(k) K060781

MEDICAL COMPRESSOR, MODELS DK50 D AND DM by Ekom S.R.O. — Product Code BTI

K060781 is an FDA 510(k) premarket notification submitted by Ekom S.R.O. for the device "MEDICAL COMPRESSOR, MODELS DK50 D AND DM". The FDA issued a decision of Substantially Equivalent on October 3, 2006. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Ekom S.R.O. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2006
Date Received
March 22, 2006
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 Ekom S.R.O.

  • K091871 — DK50 DS (October 23, 2009)

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

FDA data resources