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510(k) K030780

NEWPORT E500 WAVE VENTILATOR by Newport Medical Instruments, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2004
Date Received
March 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Newport Medical Instruments, Inc.

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  • K111146 — NEWPORT HT70 VENTILATOR (December 1, 2011)
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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)
  • K992133 — NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT (August 4, 2000)

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