K915337 is an FDA 510(k) clearance for the CAPIOX LEVEL ALARM. This device is classified as a Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (Class II - Special Controls, product code DTW).
Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 21, 1992, 87 days after receiving the submission on November 26, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4340.
| 510(k) Number | K915337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1991 |
| Decision Date | February 21, 1992 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTW — Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4340 |