Analyzer, Nitric Oxide

Device Code: 153

Product Code(s): MRP

Device Classification Information

Device Type ID153
Device NameAnalyzer, Nitric Oxide
Regulation DescriptionNitric Oxide 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 Number868.2380 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMRP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID153
DeviceAnalyzer, Nitric Oxide
Product CodeMRP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNitric Oxide Analyzer.
CFR Regulation Number868.2380 [🔎]
TPLC Last Update: 2019-04-02 19:29:48

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