The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Thermodilution Cardiac Output Computer-.
| Device ID | K830892 |
| 510k Number | K830892 |
| Device Name: | THERMODILUTION CARDIAC OUTPUT COMPUTER- |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | AMERICAN 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 | 1983-03-21 |
| Decision Date | 1983-06-15 |