510(k) K972502 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
| Applicant | Spacelabs Medical, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, May 28, 1998 |
| Received | Jul 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Spacelabs Healthcare, Incorporated Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-003 Terminated |
DSI | None listed |
| Sep 19, 2008 | Spacelabs Healthcare, Incorporated Ultraview SL Command Module, Model 90496
The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or n Terminated |
DSI | None listed |
| Sep 19, 2008 | Spacelabs Healthcare, Incorporated Ultraview SL Command Module, Model 91496
The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or n Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.