510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QZAClass II

Body Temperature Sensing Software

21 CFR 880.2915 / General Hospital
FDA source (opens on fda.gov)

QZA is the FDA product code for Body Temperature Sensing Software, a class II device type, regulated under 21 CFR 880.2915. FDA's definition for this code reads: "Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZA
Device name
Body Temperature Sensing Software
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.
Regulation
21 CFR 880.2915
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QZA

By decision year
2 clearances under product code QZA with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZA by decision year
YearClearances
20231
20251

Applicants with the most clearances

Product code QZA
Applicants holding the most 510(k) clearances under product code QZA
ApplicantClearances
Fitbit LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code