510(k) K000194 ยท LIL Monitor, Penile Tumescence
DIGITAL INFLECTION RIGIDOMETER (DIR)
| Applicant | Uroan Xxi Electromedicina, Baleares, ES |
| Decision | Substantially Equivalent, Apr 10, 2000 |
| Received | Jan 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000194
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.