510(k) K013848 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
| Applicant | U-Systems, Inc., Los Altos, CA, US |
| Decision | Substantially Equivalent, Apr 8, 2002 |
| Received | Nov 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013848
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.