510(k) K211597 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 8, 2021 |
| Received | May 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211597
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.