510(k) K002622 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
BIOSLEEP
| Applicant | Oxford Biosignals Limited, Oxford, Ox4 4 Ga, GB |
| Decision | Substantially Equivalent, Oct 23, 2000 |
| Received | Aug 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002622
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.