510(k) K152052 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound Scanner System bk2300
| Applicant | Bk Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Sep 16, 2015 |
| Received | Jul 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | B-K Medical A/S BK Medical ApS Ultrasound System Scanner bk2300 -
Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2.
The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.