The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for Optima Mpt Model 5281e And Model 5282e.
| Device ID | K897116 |
| 510k Number | K897116 |
| Device Name: | OPTIMA MPT MODEL 5281E AND MODEL 5282E |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| Contact | Duane A Schultz |
| Correspondent | Duane A Schultz TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-03-14 |