Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K163121 |
Device Name |
SmartUs EXT-1M/3M |
Applicant |
TELEMED |
DARIAUS IR GIRENO |
STR.42 |
VILNIUS,
LT
LT-02189
|
|
Applicant Contact |
YURY SOKOLOV |
Correspondent |
TELEMED |
DARIAUS IR GIRENO |
STR.42 |
VILNIUS,
LT
LT-02189
|
|
Correspondent Contact |
YURY SOKOLOV |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/08/2016 |
Decision Date | 08/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|