510(k) K002085 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRASOUND SCANNER, TYPE 1101
| Applicant | B & K Medical A/S, Dk 2820 Gentofte, DK |
| Decision | Substantially Equivalent, Aug 1, 2000 |
| Received | Jul 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002085
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.