The following data is part of a premarket notification filed by Suzhou Peaksonic Medical Technology Co., Ltd. with the FDA for Bladder Scanner, Model Name:m5.
| Device ID | K213488 |
| 510k Number | K213488 |
| Device Name: | Bladder Scanner, Model Name:M5 |
| 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 | 2021-11-01 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975124100773 | K213488 | 000 |