Atlas FDA

QZA

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Body Temperature Sensing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2915
Medical specialty
General Hospital
FDA definition
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
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RecordFirmDate
Body Temperature Software (BTS) (K243778)Fitbit, LLC2025-02-13
Body Temperature Software (BTS) (DEN230050)Fitbit, LLC2023-12-15

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