510(k) K964589 ยท KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
FLEXILOG 3000
| Applicant | Oakfield Instruments, Ltd., Oxon Ox8 1ja England, GB |
| Decision | Substantially Equivalent, Mar 4, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964589
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.