DeviceClearance

Product code QZA— General Hospital

Body Temperature Software (BTS)

Classification name
Body Temperature Sensing Software
Device class
Class 2
Regulation
21 CFR 880.2915
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QZA under 21 CFR 880.2915, via openFDA

Market context for product code QZA

FDA has cleared 2 devices under product code QZA between 2023 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZA

Recent clearances under product code QZA

Data sourced from openFDA. This site is unofficial and independent of the FDA.