Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K113184 |
Device Name |
LOGICSCAN 64 LOGICSCAN 128 |
Applicant |
TELEMED |
DARIARUS IR GIRENO STREET 42 |
VILNIUS,
LT
LT-02189
|
|
Applicant Contact |
YURY SOKOLOV |
Correspondent |
TELEMED |
DARIARUS IR GIRENO STREET 42 |
VILNIUS,
LT
LT-02189
|
|
Correspondent Contact |
YURY SOKOLOV |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/28/2011 |
Decision Date | 01/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|