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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K252676
Device Name The Circadia C300 System (C300)
Applicant
Circadia Health, Inc.
507 S Douglas St.
El Segundo,  CA  90245
Applicant Contact Timo Lauteslager
Correspondent
Circadia Health, Inc.
507 S Douglas St.
El Segundo,  CA  90245
Correspondent Contact Timo Lauteslager
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received08/25/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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