510(k) K971397 ยท ITX Transducer, Ultrasonic, Diagnostic
VIEWCATH 3-D CATHETER PULLBACK
| Applicant | Quinton, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 25, 1997 |
| Received | Apr 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971397
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.