Analyzer, Gas, Argon, Gaseous-phase

Device Code: 132

Product Code(s): JEG

Device Classification Information

Device Type ID132
Device NameAnalyzer, Gas, Argon, Gaseous-phase
Regulation DescriptionArgon 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)
Respiratory Devices Branch (RPDB)
Submission Type510(k)
CFR Regulation Number868.1075 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJEG
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 ID132
DeviceAnalyzer, Gas, Argon, Gaseous-phase
Product CodeJEG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionArgon Gas Analyzer.
CFR Regulation Number868.1075 [🔎]
TPLC Last Update: 2019-04-02 19:29:29

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