510(k) K060900 ยท OLW Index-Generating Electroencephalograph Software
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | Apr 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060900
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.