The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Heart *aid, #80.
| Device ID | K820609 |
| 510k Number | K820609 |
| Device Name: | HEART *AID, #80 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | CARDIAC RESUCITATOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-08-06 |