510(k) K142008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLABSEVEN, MYLABALPHA
| Applicant | Esaote, S.p.A., Indianpolis IN, US |
| Decision | Substantially Equivalent, Sep 12, 2014 |
| Received | Jul 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.