510(k) K921815 ยท HLT Preamplifier, Ac-Powered, Ophthalmic
TOMEY PE-300 PORTABLE ERG
| Applicant | Tomey Corporation USA, Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 15, 1992 |
| Received | Apr 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921815
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.