The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Programmable Stimulator 2352.
| Device ID | K833421 |
| 510k Number | K833421 |
| Device Name: | PROGRAMMABLE STIMULATOR 2352 |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | MEDTRONIC VASCULAR 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-03 |
| Decision Date | 1984-01-30 |