The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Impl. Programmable Bipolar Card.gen.#274.
| Device ID | K803197 |
| 510k Number | K803197 |
| Device Name: | IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | TELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-16 |
| Decision Date | 1981-01-22 |