510(k) K234153 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
| Applicant | Edgelife Technologies, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Sep 18, 2024 |
| Received | Dec 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234153
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.