510(k) K110779 ยท DQK Computer, Diagnostic, Programmable
SPACELABS SMART DISCLOSURE SYSTEM
| Applicant | Spacelabs Healthcare, Nederland CO, US |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Mar 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | Spacelabs Healthcare, Inc. Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Terminated |
DQK | None listed |
| Mar 25, 2014 | Spacelabs Healthcare, Llc Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.
Used for installing ICS G2 Clinical Access software onto hospital personal computers. Terminated |
DQK | None listed |
| Jan 17, 2013 | Spacelabs Healthcare, Llc Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03.
The Smart Disclosure product collects patient waveforms, alarms, vital Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.