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510(k) K131881

OMBRA TABLE TOP COMPRESSOR by Trudell Medical Intl. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2013
Date Received
June 25, 2013
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

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Other clearances for product code BTI

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