Spacelabs Medical Multigas Analyzer
FDA 510(k) K954962 · Spacelabs, Inc.
510(k) numberK954962
Submission
- Device name
- Spacelabs Medical Multigas Analyzer
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- October 30, 1995
- Decision date
- May 31, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | Spacelabs Medical, Inc. | 04/19/2006SE |
| 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 |
|---|---|---|
| K951605 | Spacelabs Medical Casemaster Information Management SystemDSH · Traditional | 07/14/1995SE |
| K950779 | Heart Rate Variability Software OptionDPS · Traditional | 04/25/1995SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | 10/06/1994SE |
| K923788 | Space Labs Model 90560LOS · Traditional | 12/06/1993SE |
| K912742 | Esophageal Stethoscope Temperature ProbeFLL · Traditional | 04/20/1992SE |
| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
| K904318 | Local Report GeneratorDXN · Traditional | 12/18/1990SE |
Questions and answers
When was Spacelabs Medical Multigas Analyzer cleared by the FDA?
Spacelabs Medical Multigas Analyzer (K954962) received a 510(k) decision of Substantially Equivalent on May 31, 1996, 214 days after the submission was received.
What is the product code of K954962?
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.