The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Heart - Aid Als, 95.
| Device ID | K841556 |
| 510k Number | K841556 |
| Device Name: | HEART - AID ALS, 95 |
| Classification | Enzymatic Radiochemical Assay, Tobramycin |
| Applicant | CARDIAC RESUCITATOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDO |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-07-19 |