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510(k) K131881

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

K131881 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "OMBRA TABLE TOP COMPRESSOR". The FDA issued a decision of Substantially Equivalent on October 24, 2013. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Trudell Medical Intl. has at least 10 other 510(k) clearances on record.

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

Other clearances by Trudell Medical Intl.

  • K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE (May 16, 2013)
  • K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (March 11, 2013)
  • K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (July 11, 2012)
  • K110136 — RESPICHAMBER VALVED HOLDING CHAMBER (April 18, 2011)
  • K090065 — AEROCHAMBER MINI VENTILATION CHAMBER (April 9, 2009)
  • K080926 — AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (August 12, 2008)
  • K070674 — AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLO (April 11, 2007)
  • K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER (February 27, 2006)
  • K052332 — AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (September 21, 2005)
  • K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBER (January 14, 2004)

Other clearances for product code BTI

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

FDA data resources