510(k) K971115 ยท ITX Transducer, Ultrasonic, Diagnostic
GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
| Applicant | Protek Medical Products, Inc., Iowa City IA, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Mar 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971115
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.