510(k) K061676 ยท LIL Monitor, Penile Tumescence
RIGIDOMETER, MODEL DIR-4U
| Applicant | Uroan 21, Palma De Mallorca, ES |
| Decision | Substantially Equivalent, Dec 27, 2006 |
| Received | Jun 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061676
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.