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510(k) K213518

CARESCAPE CO2 Microstream parameter by Covidien, LLC — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2022
Date Received
November 3, 2021
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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