510(k) K983985 ยท ITX Transducer, Ultrasonic, Diagnostic
HYBRISONIC SHEATH
| Applicant | Sonotech, Inc., Bellingham WA, US |
| Decision | Substantially Equivalent, Feb 25, 1999 |
| Received | Nov 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983985
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.