The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Sat-1 Oximeter/cardiac Output Computer.
| Device ID | K841401 |
| 510k Number | K841401 |
| Device Name: | SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Allan L Abati |
| Correspondent | Allan L Abati AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1985-01-14 |