510(k) K053599 ยท CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Dec 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2011 | Spacelabs Healthcare, Llc Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14.
Spacelabs Healthcare Llc.
Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, Terminated |
CBR | None listed |
| Jan 31, 2008 | Spacelabs Healthcare, Incorporated Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027 Terminated |
CBR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.