Device Listing 1670937787

Listing Summary#

Listing key: 1670937787
Premarket submission: K253288
Device: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Applicant: Esaote, S.p.A.
Product code: IYN
Decision date: 2026-04-06

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