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510(k) K252676

The Circadia C300 System (C300) by Circadia Health, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2026
Date Received
August 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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