510(k) K984580 ยท OLV Standard Polysomnograph With Electroencephalograph
BIOSACA SYSTEM
| Applicant | Biosys AB (Publ), Chester NY, US |
| Decision | Substantially Equivalent, Mar 12, 1999 |
| Received | Dec 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984580
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.