Analyzer, Gas, Isoflurane, Gaseous-phase (anesthetic Concentration)

Device Code: 161

Product Code(s): NHQ

Definition: A Isoflurane Gas Analyzer Is A Device Intended To Measure The Concentration Of Isoflurane Anesthetic In A Gas Mixture

Device Classification Information

Device Type ID161
Device NameAnalyzer, Gas, Isoflurane, Gaseous-phase (anesthetic Concentration)
Regulation DescriptionEnflurane Gas Analyzer.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNHQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID161
DeviceAnalyzer, Gas, Isoflurane, Gaseous-phase (anesthetic Concentration)
Product CodeNHQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEnflurane Gas Analyzer.
CFR Regulation Number868.1500 [🔎]
TPLC Last Update: 2019-04-02 19:29:55

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.