The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Cardiac 1000 Tm.
| Device ID | K811094 |
| 510k Number | K811094 |
| Device Name: | CARDIAC 1000 TM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-21 |
| Decision Date | 1981-07-28 |