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510(k) K041406

NEWPORT C250 AIR COMPRESSOR MODEL C250 by Newport Medical Instruments — Product Code BTI

K041406 is an FDA 510(k) premarket notification submitted by Newport Medical Instruments for the device "NEWPORT C250 AIR COMPRESSOR MODEL C250". The FDA issued a decision of Substantially Equivalent on December 15, 2004. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Newport Medical Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2004
Date Received
May 26, 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 Newport Medical Instruments

  • K121891 — NEWPORT AURA VENTILATOR (November 9, 2012)
  • K111146 — NEWPORT HT70 VENTILATOR (December 1, 2011)
  • K101803 — NEWPORT E360 VENTILATOR (September 8, 2010)
  • K090888 — NEWPORT HT70 FAMILY OF VENTILATORS (November 18, 2009)
  • K082724 — NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM (December 16, 2008)
  • K061094 — NEWPORT E500 WAVE VENTILATOR (July 28, 2006)
  • K053502 — NEWPORT E360 VENTILATOR (January 10, 2006)
  • K041082 — NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (September 7, 2004)
  • K030780 — NEWPORT E500 WAVE VENTILATOR (January 23, 2004)
  • K992133 — NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT (August 4, 2000)

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)
  • 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