QZA — Body Temperature Sensing Software Class II
FDA product code QZA covers "Body Temperature Sensing Software", a Class II medical device regulated under 21 CFR 880.2915. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.