K071730 is an FDA 510(k) clearance for the STUDIODOP VICORDER. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Skidmore Medical, Limited (Evergreen, US). The FDA issued a Cleared decision on December 20, 2007, 178 days after receiving the submission on June 25, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K071730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2007 |
| Decision Date | December 20, 2007 |
| Days to Decision | 178 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOP — Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |