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FDA 510(k) Applications Submitted by Massimo Polignano
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180592
03/06/2018
G-scan Brio
Esaote S.p.A
K161359
05/16/2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Esaote S.p.A
K162290
08/15/2016
MyLabSix CrystaLine
ESAOTE S.P.A.
K173291
10/16/2017
6440 Ultrasound System
Esaote S.p.A
K163082
11/03/2016
6200 Ultrasound System and 6250 Ultrasound System
ESAOTE S.P.A
K183191
11/19/2018
6420 Ultrasound System
Esaote, S.p.A.
K183685
12/28/2018
O-Scan
Esaote S.p.A
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