The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Option 301 Pacemaker Eval. Module Mac-1.
| Device ID | K802368 |
| 510k Number | K802368 |
| Device Name: | OPTION 301 PACEMAKER EVAL. MODULE MAC-1 |
| Classification | Electrocardiograph |
| Applicant | MARQUETTE ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-29 |
| Decision Date | 1981-03-04 |