510(k) K041639 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
| Applicant | Envisioneering, LLC, St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Jun 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041639
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.