Spacelabs Medical Multigas Analyzer Module 91518 and Accessories
FDA 510(k) K053599 · Spacelabs Medical, Inc.
510(k) numberK053599
Submission
- Device name
- Spacelabs Medical Multigas Analyzer Module 91518 and Accessories
- Applicant
- Spacelabs Medical, Inc.
Issaquah, WA, US - Received
- December 23, 2005
- Decision date
- April 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1700
- Specialty
- Anesthesiology
Other 510(k)s with product code CBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112173 | Speacelabs Multigas ModuleCBR · Special | Spacelabs Healthcare | 10/05/2011SE |
| 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 |
More from Erich Jaeger, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120616 | Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special | 03/29/2012SE |
| K112962 | Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)MHX · Special | 11/02/2011SE |
| K102422 | Spacelabs Medical Patient MonitorsMHX · Special | 12/07/2010SE |
| K093501 | Elance Vital Signs Monitor and Elance Central StationMHX · Special | 11/24/2009SE |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special | 08/01/2008SE |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional | 03/15/2007SE |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated | 09/29/2006SE |
| K062278 | Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special | 09/19/2006SE |
| K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional | 06/23/2006SE |
| K050605 | Spacelabs Medical Multiparameter Module 91496DSI · Special | 05/03/2005SE |
Questions and answers
When was Spacelabs Medical Multigas Analyzer Module 91518 and Accessories cleared by the FDA?
Spacelabs Medical Multigas Analyzer Module 91518 and Accessories (K053599) received a 510(k) decision of Substantially Equivalent on April 19, 2006, 117 days after the submission was received.
What is the product code of K053599?
The FDA product code is CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1700.