Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K161968 |
Device Name |
MicrUs |
Applicant |
TELEMED |
Dariaus ir Gireno str.42 |
Vilnius,
LT
LT-02189
|
|
Applicant Contact |
Yury Sokolov |
Correspondent |
Medical Imaging Innovations |
Dariaus ir Gireno str. 42 |
Vilnius,
LT
|
|
Correspondent Contact |
Yury Sokolov |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/18/2016 |
Decision Date | 11/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|