The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Biotrend Oxygen Saturation And Hematocrit System.
| Device ID | K093650 |
| 510k Number | K093650 |
| Device Name: | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Jeffrey Koll |
| Correspondent | Jeffrey Koll MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994750280 | K093650 | 000 |
| 00613994638656 | K093650 | 000 |
| 00613994638649 | K093650 | 000 |
| 00643169200906 | K093650 | 000 |
| 00763000216238 | K093650 | 000 |
| 00763000216221 | K093650 | 000 |
| 00763000216269 | K093650 | 000 |
| 00763000216276 | K093650 | 000 |
| 00763000167332 | K093650 | 000 |