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510(k) K243778

Body Temperature Software (BTS) by Fitbit, LLC — Product Code QZA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 13, 2025
Date Received: December 9, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Body Temperature Sensing Software
Device Class: Class II
Regulation Number: 880.2915
Review Panel: HO
Submission Type

Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.