510(k) K833454 ยท LIL Monitor, Penile Tumescence
BIOREM 3000 & 4000
| Applicant | Biorem, Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 21, 1984 |
| Received | Sep 28, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833454
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.