Clearance Summary
THERMAPAD received FDA 510(k) clearance under submission number K864158, sponsored by Avail-Southwest Division. 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 1987-03-02.
- Submission: K864158
- Applicant / Sponsor: Avail-Southwest Division
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1987-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KME and 21 CFR 880.6060, within the General Hospital review panel as a Class I device.