K992857 is an FDA 510(k) clearance for the LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070. This device is classified as a Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (Class II - Special Controls, product code DTW).
Submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 10, 1999, 77 days after receiving the submission on August 25, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4340.
| 510(k) Number | K992857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1999 |
| Decision Date | November 10, 1999 |
| Days to Decision | 77 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 |