510(k) K974173 ยท LKY Device, External Penile Rigidity
ERECAID SYSTEM/STAY EREC SYSTEM
| Applicant | Imagyn Medical Technologies, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Nov 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974173
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.