510(k) K232808 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Butterfly iQ3 Ultrasound System
| Applicant | Butterfly Network, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jan 4, 2024 |
| Received | Sep 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232808
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.