← FDA Medical Device Classifications
Body Temperature Sensing Software
QZA · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2915
Classification
- FDA Product Code
QZA- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.2915
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown