QZA

Body Temperature Sensing Software

Product code
QZA
Device name
Body Temperature Sensing Software
Device class
Class 2
21 CFR
21 CFR 880.2915
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-02-13.

NumberDecision dateApplicantDevice nameSummary
K2437782025-02-13Fitbit, LLCBody Temperature Software (BTS)PDF
DEN2300502023-12-15Fitbit, LLCBody Temperature Software (BTS)

1 summaries are archived here for direct download.

Official FDA classification page: QZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).