Clearance Summary
ACCA-TEMP SKIN TEMP. VINYL DISC received FDA 510(k) clearance under submission number K823221, sponsored by T. G. & E. Medical. 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 1983-01-12.
- Submission: K823221
- Applicant / Sponsor: T. G. & E. Medical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2200
- Decision date: 1983-01-12
Classification & Regulation
This clearance is catalogued under FDA product code KPD and 21 CFR 880.2200, within the General Hospital review panel as a Class II device.