K191307 is an FDA 510(k) clearance for the Palm Bladder Scanner - PBSV5.1. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Mianyang Meike Electronic Equipment Co., Ltd. (Mianyang, CN). The FDA issued a Cleared decision on June 5, 2019, 22 days after receiving the submission on May 14, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K191307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2019 |
| Decision Date | June 05, 2019 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |