510(k) K230346 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson SWIFT; Voluson SWIFT+
| Applicant | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jun 20, 2023 |
| Received | Feb 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230346
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.