The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Sat-2 Oximeter/cardiac Output Computer.
| Device ID | K884329 |
| 510k Number | K884329 |
| Device Name: | SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER |
| Classification | Oximeter |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Edward Guilmette |
| Correspondent | Edward Guilmette BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1988-12-16 |