K152582 is an FDA 510(k) clearance for the CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on December 3, 2015, 84 days after receiving the submission on September 10, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K152582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2015 |
| Decision Date | December 03, 2015 |
| Days to Decision | 84 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSK — Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |