510(k) K983665 ยท KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
MANOMETRIC ASSEMBLIES
| Applicant | Dentsleeve Pty., Ltd., Parkside South Australia, AU |
| Decision | Substantially Equivalent, May 17, 1999 |
| Received | Oct 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983665
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.