The following data is part of a premarket notification filed by Mianyang Meike Electronic Equipment Co., Ltd. with the FDA for Palm Bladder Scanner - Pbsv5.1.
| Device ID | K191307 |
| 510k Number | K191307 |
| Device Name: | Palm Bladder Scanner - PBSV5.1 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Mianyang Meike Electronic Equipment Co., Ltd. No. 63, Yinping Road, Longmen Town Fucheng District 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 | 2019-05-14 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06940912715019 | K191307 | 000 |