510(k) K050605 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, May 3, 2005 |
| Received | Mar 10, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2007 | Spacelabs Healthcare, Incorporated Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor. Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.