510(k) K842616 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS ALPHA PC PATIENT COMPUTER
| Applicant | Spacelabs, Inc., Chatsworth CA, US |
| Decision | Substantially Equivalent, Oct 18, 1984 |
| Received | Jul 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2012 | Spacelabs Healthcare, Llc Ultraview SL 91493 Integrated Module Housing.
PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter Terminated |
DSI | None listed |
| Nov 3, 2005 | Spacelabs Medical Incorporated Tru-Link DIN unshielded ECG cable, 5-lead Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.