510(k) K212704 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
| Applicant | Philips Medical Systems, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 24, 2021 |
| Received | Aug 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212704
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.