K182460 is an FDA 510(k) clearance for the MD-6000P Bladder Scanner. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by MEDA Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on May 6, 2019, 238 days after receiving the submission on September 10, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K182460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2018 |
| Decision Date | May 06, 2019 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |