K150530 is an FDA 510(k) clearance for the Level Sensor, Level Sensor Tape. This device is classified as a Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (Class II - Special Controls, product code DTW).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 8, 2015, 67 days after receiving the submission on March 2, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4340.
| 510(k) Number | K150530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2015 |
| Decision Date | May 08, 2015 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTW — Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4340 |