510(k) K082893 ยท ITX Transducer, Ultrasonic, Diagnostic
PRAGER SHELL
| Applicant | Esi, Inc., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082893
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.