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510(k) K253436

c-med0 alpha by Cosinuss GmbH — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2026
Date Received
October 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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