The following data is part of a premarket notification filed by Suzhou Peaksonic Medical Technology Co., Ltd with the FDA for Bladder Scanner (model: M3, M3-hd, M4, M4-hd).
| Device ID | K201316 |
| 510k Number | K201316 |
| Device Name: | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Suzhou Peaksonic Medical Technology Co., Ltd 2A, West Side Of Building G4, Kunshan Hi-Tech Medical Device Industrial Park Qiandeng, Kunshan, Suzhou, CN 215341 |
| Contact | Calvin Ma |
| Correspondent | Calvin Ma Suzhou Peaksonic Medical Technology Co., Ltd 2A, West Side Of Building G4, Kunshan Hi-Tech Medical Device Industrial Park Qiandeng, Kunshan, Suzhou, CN 215341 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-18 |
| Decision Date | 2021-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975124100537 | K201316 | 000 |
| 06975124100421 | K201316 | 000 |