510(k) K970515 ยท ITX Transducer, Ultrasonic, Diagnostic
GENERAL PURPOSE LATEX TRANSDUCER COVERS
| Applicant | CIVCO Medical Instruments Co., Inc., Kalona IA, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | Feb 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970515
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.