Clearance Summary
OPTIMA MPT MODEL 5281E AND MODEL 5282E received FDA 510(k) clearance under submission number K897116, sponsored by Telectronics Pacing Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-03-14.
- Submission: K897116
- Applicant / Sponsor: Telectronics Pacing Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1990-03-14
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.