510(k) K252148 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Butterfly Gestational Age Tool
| Applicant | Butterfly Network, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Jul 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252148
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.