510(k) K003041 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRASOUND SCANNER TYPE 2101
| Applicant | B-K Medical A/S, Gentofte, DK |
| Decision | Substantially Equivalent, Feb 7, 2001 |
| Received | Sep 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003041
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.