The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Pace* Aid Model 50.
| Device ID | K820507 |
| 510k Number | K820507 |
| Device Name: | PACE* AID MODEL 50 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | CARDIAC RESUCITATOR CORP. 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 | 1982-02-25 |
| Decision Date | 1982-08-06 |