Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K153529 |
Device Name |
WS80A Diagnostic Ultrasound System |
Applicant |
SAMSUNG MEDISON CO., LTD. |
42, TEHERAN-RO 108-GIL |
GANGNAM-GU |
SEOUL,
KR
|
|
Applicant Contact |
Kyeong-Mi Park |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/09/2015 |
Decision Date | 02/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|