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
1608423370
Device Listing 1608423370
Listing Summary
#
Listing key
1608423370
Premarket submission
DEN250007
Device
Delivery Date AI
Applicant
Ultrasound AI
Product code
SHE
Decision date
2026-02-11
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
349568
3044467584
3044467584
ULTRASOUND AI INC.
1
N
2026-01-01
4349 Ivycrest Pt Highlands Ranch CO US 80130