Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K213070 |
Device Name |
MD-320W Ultrasound Biomicroscope |
Applicant |
Meda Co., LTD |
F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, |
Huayuan Industry Development Area |
Tianjin,
CN
300384
|
|
Applicant Contact |
Linda Zhang |
Correspondent |
Meda Co., LTD |
F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, |
Huayuan Industry Development Area |
Tianjin,
CN
300384
|
|
Correspondent Contact |
Linda Zhang |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2021 |
Decision Date | 11/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|