510(k) K083667 ยท ITX Transducer, Ultrasonic, Diagnostic
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Feb 2, 2009 |
| Received | Dec 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083667
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.