The following data is part of a premarket notification filed by Meda Co., Ltd with the FDA for Md-6000p Bladder Scanner.
| Device ID | K182460 |
| 510k Number | K182460 |
| Device Name: | MD-6000P Bladder Scanner |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Meda Co., LTD F2C,F3D,F4C,F5, F6C, Bldg C2, Xinmao Science Skill Park, Huayuan Ind. Area Tianjin, CN 300384 |
| Contact | Linda Zhang |
| Correspondent | Kai Chen Meditech International, Inc. (United States Designated Agent Of MEDA Co., Ltd) Potomac, MD 20854 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-05-06 |