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Company-Registration
1751804346
Device Listing 1751804346
Listing Summary
#
Listing key
1751804346
Premarket submission
K190989
Device
6400 Ultrasound System (MyLabX6, MyLabX7)
Applicant
Esaote, S.p.A.
Product code
IYN
Decision date
2019-05-10
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
9836
9611125
3002806925
Kim Akers
1
N
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