The following data is part of a premarket notification filed by Ross Research, Inc. with the FDA for Pacemaker Pulse Generator W/electrode.
| Device ID | K840353 |
| 510k Number | K840353 |
| Device Name: | PACEMAKER PULSE GENERATOR W/ELECTRODE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ROSS RESEARCH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-26 |
| Decision Date | 1984-04-23 |