Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K211248 |
Device Name |
ArtUs |
Applicant |
Telemed |
Highway Business Centre Savanoriu pr. 178A |
Vilnius,
LT
LT-03154
|
|
Applicant Contact |
Yury Sokolov |
Correspondent |
Telemed |
Highway Business Centre Savanoriu pr. 178A |
Vilnius,
LT
LT-03154
|
|
Correspondent Contact |
Yury Sokolov |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/26/2021 |
Decision Date | 02/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|