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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Loss Of Pulse Notification Software
510(k) Number K242967
Device Name Loss of Pulse Detection
Applicant
Fitbit
215 Fremont Street
San Francisco,  CA  94105
Applicant Contact Dinesh Puppala
Correspondent
Fitbit
215 Fremont Street
San Francisco,  CA  94105
Correspondent Contact Dinesh Puppala
Regulation Number870.2790
Classification Product Code
SDY  
Date Received09/26/2024
Decision Date 02/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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