510(k) K231301 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 15, 2023 |
| Received | May 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231301
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.