510(k) K121384 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLABSOGNO
| Applicant | Esaote, S.p.A., Indianpolis IN, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | May 8, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2014 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348).
Provides imaging for guidance of biopsy and imaging to assist in the placement of n Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.