510(k) K063490 ยท DQK Computer, Diagnostic, Programmable
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Mar 15, 2007 |
| Received | Nov 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063490
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2010 | Spacelabs Healthcare, Incorporated Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.