The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Heart-aid Model 80.
| Device ID | K843358 |
| 510k Number | K843358 |
| Device Name: | HEART-AID MODEL 80 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | CARDIAC RESUCITATOR CORP. 25117 S.W. PKWY. Wilsonville, OR 97070 |
| Contact | Bruce Haggar |
| Correspondent | Bruce Haggar CARDIAC RESUCITATOR CORP. 25117 S.W. PKWY. Wilsonville, OR 97070 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-11-19 |