Clearance Summary
HEALTHCHECK THERM-STRIP received FDA 510(k) clearance under submission number K863181, sponsored by Healthcheck Corp.. 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 1986-09-11.
- Submission: K863181
- Applicant / Sponsor: Healthcheck Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2900
- Decision date: 1986-09-11
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.