510(k) K972282 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS MEDICAL PCIS PATIENT MONITORS
| Applicant | Spacelabs Medical, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Sep 25, 1997 |
| Received | Jun 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2011 | Spacelabs Healthcare, Llc Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option.
Product Usage: Spacelabs Medical PCIS patient monitors passively di Terminated |
MHX | None listed |
| Jan 19, 2010 | Spacelabs Healthcare, Incorporated Spacelabs Model 91367 SL 2200 Compact Monitor
Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, Terminated |
DXJ | None listed |
| Jan 19, 2010 | Spacelabs Healthcare, Incorporated Spacelabs Model 91369-24 SL 2400 Compact Monitor
Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyze Terminated |
DXJ | None listed |
| Jan 19, 2010 | Spacelabs Healthcare, Incorporated Spacelabs Model 91370 SL 2600 Compact Monitor
Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, Terminated |
DXJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.