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510(k) K162343

Westmed Gas Sampling Cannula with O2 delivery by Westmed, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
August 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Westmed, Inc.

  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR (May 23, 2014)
  • K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (December 6, 2012)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K072220 — PEDI CO2 EASY (August 23, 2007)
  • K070128 — CO2 EASY (February 15, 2007)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)

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