510(k) K050313 ยท GWY Pinwheel
BIS SRS (SEMI-RESUABLE SENSOR)
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Feb 24, 2005 |
| Received | Feb 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050313
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.