Clearance Summary
THERMOMETER, SINGLE USE, STRIP, TEMPADOT received FDA 510(k) clearance under submission number K771037, 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 1977-06-27.
- Submission: K771037
- Applicant / Sponsor: Info-Chem
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 1977-06-27
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.