Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K221599 |
Device Name |
HS40 Diagnostic Ultrasound System |
Applicant |
Samsung Medison Co., Ltd. |
3366, Hanseo-ro, Nam-myeon, |
Hongcheon-gun,
KR
25108
|
|
Applicant Contact |
Jee Young Ju |
Correspondent |
Samsung Medison Co., Ltd. |
3366, Hanseo-ro, Nam-myeon, |
Hongcheon-gun,
KR
25108
|
|
Correspondent Contact |
Jee Young Ju |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/02/2022 |
Decision Date | 08/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|