The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Biotrend Oxygen Saturation & Hematocrit System.
| Device ID | K954501 |
| 510k Number | K954501 |
| Device Name: | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1996-01-16 |