The following data is part of a premarket notification filed by Suzhou Lischka Medtech Co., Ltd. with the FDA for Bladder Scanner (models: M2, M2-w, M1, M1-w).
| Device ID | K190769 |
| 510k Number | K190769 |
| Device Name: | Bladder Scanner (Models: M2, M2-W, M1, M1-W) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Suzhou Lischka Medtech Co., Ltd. NO.999 Qujia Road, Qiandeng Town Kunshan, CN 215341 |
| Contact | Shi Jing |
| Correspondent | Shi Jing Suzhou Lischka Medtech Co., Ltd. NO.999 Qujia Road, Qiandeng Town Kunshan, 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 | 2019-03-26 |
| Decision Date | 2019-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972608310017 | K190769 | 000 |
| 06972608310055 | K190769 | 000 |
| 06972608310086 | K190769 | 000 |
| 06972608310079 | K190769 | 000 |
| 06972608310062 | K190769 | 000 |
| 06975124100285 | K190769 | 000 |
| 06975124100193 | K190769 | 000 |