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510(k) K123690

CAPNOSTREAM20P WITH HIFI C02 MONITORING by Oridion Medical 1987 , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2014
Date Received
December 3, 2012
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

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  • K024300 — MICROCAP PLUS/NPB-75 (April 3, 2003)
  • K013845 — MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE (November 29, 2001)

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