CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class II

FDA Device Classification

FDA product code CBR covers "Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)", a Class II medical device regulated under 21 CFR 868.1700. Submissions are reviewed by the Anesthesiology panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CBR
Device Class
Class II
Regulation Number
868.1700
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K112173spacelabs healthcareSPEACELABS MULTIGAS MODULEOctober 5, 2011
K053599spacelabs medicalSPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESApril 19, 2006
K954962spacelabsSPACELABS MEDICAL MULTIGAS ANALYZERMay 31, 1996
K904843dalton instrumentOSCAR(TM) II CAPNOMETER & PULSE OXIMETERApril 9, 1991
K853360erich jaegerN20 TESTSeptember 3, 1985