Clearance Summary
EPISENSOR PLUS received FDA 510(k) clearance under submission number K920740, sponsored by Industrias Palex C/O Dma Med-Chem 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 1994-03-07.
- Submission: K920740
- Applicant / Sponsor: Industrias Palex C/O Dma Med-Chem Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2460
- Decision date: 1994-03-07
Classification & Regulation
This clearance is catalogued under FDA product code CAR and 21 CFR 880.2460, within the General Hospital review panel as a Class II device.