510(k) K973596 ยท OLW Index-Generating Electroencephalograph Software
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
| Applicant | Spacelabs Medical, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Feb 3, 1998 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973596
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.