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
2024998598
Device Listing 2024998598
Listing Summary
#
Listing key
2024998598
Premarket submission
K061755
Device
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
Applicant
Esaote Europe B.V.
Product code
IYO
Decision date
2006-08-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9838
1826555
1826555
Esaote North America, Inc
1
Y
2026-01-01
11907 Exit Five Parkway Fishers IN US 46037
200815
3012981490
3012981490
ESAOTE S.P.A.
1
N
2026-01-01
Via degli Olmi 11 Sesto Fiorentino Firenze IT 50019
201179
3012987001
3012987001
Proton B.V.
1
N
2026-01-01
Dr. Nolenslaan 157/J GM Sittard Limburg NL 6136