510(k) K000338 ยท OLV Standard Polysomnograph With Electroencephalograph
VITAPORT 3
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 26, 2000 |
| Received | Feb 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000338
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.