K153762 is an FDA 510(k) clearance for the Smartdop XT6. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Koven Technology, Inc. (St Louis, US). The FDA issued a Cleared decision on May 25, 2016, 147 days after receiving the submission on December 30, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K153762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2015 |
| Decision Date | May 25, 2016 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |