510(k) K231764 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound System 1300
| Applicant | Bk Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Oct 23, 2023 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2025 | B-K Medical A/S Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.