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510(k) K201590

EMMA Capnograph by Masimo Corporation — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2021
Date Received
June 12, 2020
Clearance Type
Special
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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