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510(k) DEN230050

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

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 15, 2023
Date Received: July 17, 2023
Clearance Type: Direct
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.