The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Pace-1a Cardiac Stimulator.
| Device ID | K963579 |
| 510k Number | K963579 |
| Device Name: | PACE-1A CARDIAC STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Amy J Laforte, Ph.d |
| Correspondent | Amy J Laforte, Ph.d RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-06 |
| Decision Date | 1996-11-08 |