Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1885829224
Device Listing 1885829224
Listing Summary
#
Listing key
1885829224
Premarket submission
K191115
Device
RS85 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
Product code
IYN
Decision date
2019-06-12
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
11496
8041160
3010289997
Ninad Gujar
1
N
2026-01-01
14 Electronics Ave Danvers MA US 01923
158982
3009758186
3009758186
SAMSUNG MEDISON CO., LTD.
1
N
2026-01-01
244, 1gongdan-ro Gumi-si Gyeongbuk KR 39376