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
1619251670
Device Listing 1619251670
Listing Summary
#
Listing key
1619251670
Premarket submission
K103737
Device
OMNI II PATIENT MONITOR
Applicant
Infinium Medical
Product code
MWI
Decision date
2011-06-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
186896
1000122786
1000122786
DRE Medical Group Inc.
1
Y
2020-04-25
2601 Stanley Gault PKWY Louisville KY US 40223