510(k) K001013 ยท OLV Standard Polysomnograph With Electroencephalograph
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
| Applicant | Airsep Corp., Buffalo NY, US |
| Decision | Substantially Equivalent, May 16, 2000 |
| Received | Mar 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001013
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.