The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Computer, Thermodilution Cardiac (9520).
| Device ID | K760192 |
| 510k Number | K760192 |
| Device Name: | COMPUTER, THERMODILUTION CARDIAC (9520) |
| 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 | 1976-07-06 |
| Decision Date | 1976-07-19 |