510(k) K161359 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
| Applicant | Esaote, S.p.A., Genova, IT |
| Decision | Substantially Equivalent, Jul 19, 2016 |
| Received | May 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2020 | ESAOTE S.P.A AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in Terminated |
IYN | None listed |
| Sep 8, 2020 | ESAOTE S.P.A AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in Terminated |
IYN | None listed |
| Jun 11, 2018 | ESAOTE S.P.A. MyLab Alpha, Model 7400 Terminated |
IYN | None listed |
| Jun 11, 2018 | ESAOTE S.P.A. MyLab Gamma, Model 7410 Terminated |
IYN | None listed |
| Jun 11, 2018 | ESAOTE S.P.A. MyLab Seven, Model 6400 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.