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510(k) K253030

Capnostream™35 Portable Respiratory Monitor (PM35MN) by Covidien, LLC — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
September 19, 2025
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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