K093650 is an FDA 510(k) clearance for the BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM. This device is classified as a Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DTY).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on February 17, 2010, 84 days after receiving the submission on November 25, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4410.
| 510(k) Number | K093650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2009 |
| Decision Date | February 17, 2010 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTY — Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4410 |