The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Pace *aid Model 52.
| Device ID | K843547 |
| 510k Number | K843547 |
| Device Name: | PACE *AID MODEL 52 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | CARDIAC RESUCITATOR CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Bruce Haggar |
| Correspondent | Bruce Haggar 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 | 1984-09-10 |
| Decision Date | 1984-12-17 |