Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
FDA product code CBR · Class II (moderate risk) · 21 CFR 868.1700 · Anesthesiology
5510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112173 | Speacelabs Multigas ModuleCBR · Special | Spacelabs Healthcare | 10/05/2011SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | Spacelabs Medical, Inc. | 04/19/2006SE |
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | Spacelabs, Inc. | 05/31/1996SE |
| K904843 | Oscar(Tm) II Capnometer & Pulse OximeterCBR · Traditional | Dalton Instrument Corp. | 04/09/1991SE |
| K853360 | N20 TestCBR · Traditional | Erich Jaeger, Inc. | 09/03/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2077-2014 Class II | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09).…With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high… | Spacelabs Healthcare Inc | 06/18/2014Terminated |
| Z-2902-2011 | Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs…Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent… | Spacelabs Healthcare, Llc | 06/08/2011Terminated |
| Z-0660-2008 | Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare…Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. | Spacelabs Healthcare, Incorporated | 10/08/2007Terminated |