510(k) K080461 ยท MLD Monitor, St Segment With Alarm
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Mar 13, 2008 |
| Received | Feb 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080461
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.