The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medsat Oxygen Saturation System.
| Device ID | K941922 |
| 510k Number | K941922 |
| Device Name: | MEDSAT OXYGEN SATURATION SYSTEM |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Roberta Thompson |
| Correspondent | Roberta Thompson MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-20 |
| Decision Date | 1995-02-17 |