510(k) K823561 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
URETHRAL PRESSURE PROFILE & TEMP. MODUL
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Jan 7, 1983 |
| Received | Dec 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823561
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.