Body Temperature Sensing Software
The body temperature sensing software (product code QZA) is a Class 2 General Hospital software device (regulation 880.2915) used for the determination of human body temperature by analyzing input sensor data. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZA
- Device Class
- FDA class 2
- Regulation Number
- 880.2915
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.