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
1212317517
Device Listing 1212317517
Listing Summary
#
Listing key
1212317517
Premarket submission
K191233
Device
ARIETTA 750
Applicant
Hitachi Healthcare Americas
Product code
IYN
Decision date
2019-08-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
294287
3019784575
3019784575
Randy Vader
1
N
2026-01-01
81 Hartwell Ave Ste 100 Lexington MA US 02421
330648
3032109225
3032109225
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
1
N
2026-01-01
2-1, Shintoyofuta Kashiwa-shi Chiba JP 277-0804