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QZA — Body Temperature Sensing Software Class II

FDA Device Classification

Classification Details

Product Code
QZA
Device Class
Class II
Regulation Number
880.2915
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243778fitbitBody Temperature Software (BTS)February 13, 2025
DEN230050fitbitBody Temperature Software (BTS)December 15, 2023