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
1988661620
Device Listing 1988661620
Listing Summary
#
Listing key
1988661620
Premarket submission
K260533
Device
ELISIO™-H
Applicant
Nipro Medical Corporation
Product code
KDI
Decision date
2026-03-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
10566
9610987
3002807710
NIPRO CORPORATION ODATE FACTORY
1
N
2026-01-01
8-7, Hanukiyachi, Niida ODATE-SHI Akita JP 018-5794
214137
3000247873
3000247873
JESSICA OSWALD-MCLEOD
1
N
2026-01-01
3150 NW 107th Ave Doral FL US 33172