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510(k) K070128

CO2 EASY by Westmed, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2007
Date Received
January 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

  • K162343 — Westmed Gas Sampling Cannula with O2 delivery (December 14, 2016)
  • 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)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)

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