510(k) K992178 ยท ITX Transducer, Ultrasonic, Diagnostic
BALLOON FOR ULTRASONIC ENDOSCOPES
| Applicant | N.M. Beale Co., Inc., Harvard MA, US |
| Decision | Substantially Equivalent, May 12, 2000 |
| Received | Jun 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992178
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.