The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Thermodilution Cardiac Output Computer, Mod. Com-2.
| Device ID | K872529 |
| 510k Number | K872529 |
| Device Name: | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Hayim Zadaca |
| Correspondent | Hayim Zadaca AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-26 |
| Decision Date | 1987-09-15 |