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510(k) K860373

THE M100 AIR/OXYGEN MIXER by Newport Medical Instruments, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1986
Date Received
February 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

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  • 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)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041082 — NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (September 7, 2004)
  • K030780 — NEWPORT E500 WAVE VENTILATOR (January 23, 2004)

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