510(k) K163082 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6200 Ultrasound System and 6250 Ultrasound System
| Applicant | Esaote, S.p.A., Genova, IT |
| Decision | Substantially Equivalent, Mar 16, 2017 |
| Received | Nov 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2018 | ESAOTE S.P.A. MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 Terminated |
IYN | None listed |
| Jan 3, 2018 | ESAOTE S.P.A. MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.