The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Saturation/hematocrit Monitor System.
| Device ID | K910421 |
| 510k Number | K910421 |
| Device Name: | SATURATION/HEMATOCRIT MONITOR SYSTEM |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Norma Lowe |
| Correspondent | Norma Lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-10-15 |