The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Cardiac Output Computer, Mdel 9520a.
| Device ID | K790047 |
| 510k Number | K790047 |
| Device Name: | CARDIAC OUTPUT COMPUTER, MDEL 9520A |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-05 |
| Decision Date | 1979-02-26 |