510(k) K043524 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
| Applicant | B-K Medical A/S, Herlev, DK |
| Decision | Substantially Equivalent, Jan 13, 2005 |
| Received | Dec 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2008 | B & K Medical Systems, Inc. B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.