The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for External Test Pulse Generator.
| Device ID | K780717 |
| 510k Number | K780717 |
| Device Name: | EXTERNAL TEST PULSE GENERATOR |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | VITATRON MEDICAL BV 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-27 |
| Decision Date | 1978-06-30 |