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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Body Temperature Sensing Software
510(k) Number K243778
Device Name Body Temperature Software (BTS)
Applicant
Fitbit, LLC
215 Fremont St.
San Francisco,  CA  94105
Applicant Contact Nathan Austin
Correspondent
Fitbit, LLC
215 Fremont St.
San Francisco,  CA  94105
Correspondent Contact Nathan Austin
Classification Product Code
QZA  
Date Received12/09/2024
Decision Date 02/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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