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510(k) K171765

Nihon Kohden CO2 Monitor by Nihon Kohden Corporation — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2017
Date Received
June 14, 2017
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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