Clearance Summary
MODIFIED TEMPA-DOT THERMOMETER received FDA 510(k) clearance under submission number K791574, sponsored by Info-Chem. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-09-12.
- Submission: K791574
- Applicant / Sponsor: Info-Chem
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 1979-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FQZ and 21 CFR 880.2900, within the General Hospital review panel as a Class I device.