510(k) K980627 ยท LIL Monitor, Penile Tumescence
NEVA SYSTEM
| Applicant | Urometrics, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 7, 1998 |
| Received | Feb 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980627
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.