510(k) K991446 ยท OLV Standard Polysomnograph With Electroencephalograph
BIOSACA SYSTEM, MODEL 800
| Applicant | Biosys AB (Publ), Chester NY, US |
| Decision | Substantially Equivalent, Jul 23, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991446
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.