Clearance Summary
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON received FDA 510(k) clearance under submission number K844856, sponsored by Bristol Medical Electronics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-02-20.
- Submission: K844856
- Applicant / Sponsor: Bristol Medical Electronics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1985-02-20
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.