The following data is part of a premarket notification filed by Mianyang Meike Electronic Equipment Co., Ltd. with the FDA for Palm Bladder Scanner - Pbsv7.1.
| Device ID | K210591 |
| 510k Number | K210591 |
| Device Name: | Palm Bladder Scanner - PBSV7.1 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Mianyang Meike Electronic Equipment Co., Ltd. No., 63, Yinping Road, Longmen Town, Fucheng District, Mianyang. Sichuan Mianyang, CN 621000 |
| Contact | Wenjun Zhao |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou, CN 325000 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-06-09 |