Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
The Gaseous-Phase Nitrous Oxide Anesthetic Concentration Analyzer is an anesthesiology device that measures the concentration of nitrous oxide in the gas phase of a breathing circuit, allowing clinicians to monitor and control the delivery of this anesthetic gas during surgical procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBR, regulated under 21 CFR 868.1700, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CBR
- Device Class
- FDA class 2
- Regulation Number
- 868.1700
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K112173 | SPEACELABS MULTIGAS MODULE | Oct 05, 2011 | Substantially Equivalent | Spacelabs Healthcare |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | Apr 19, 2006 | Substantially Equivalent | Spacelabs Medical, Inc. |
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | May 31, 1996 | Substantially Equivalent | Spacelabs, Inc. |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Apr 09, 1991 | Substantially Equivalent | Dalton Instrument Corp. |
| K853360 | N20 TEST | Sep 03, 1985 | Substantially Equivalent | Erich Jaeger, Inc. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.