The following data is part of a premarket notification filed by Meda Co., Ltd with the FDA for Md-320w Ultrasound Biomicroscope.
| Device ID | K213070 |
| 510k Number | K213070 |
| Device Name: | MD-320W Ultrasound Biomicroscope |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Meda Co., LTD F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin, CN 300384 |
| Contact | Linda Zhang |
| Correspondent | Linda Zhang Meda Co., LTD F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin, CN 300384 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2021-11-18 |