Plethysmograph, Volume

Device Code: 133

Product Code(s): JEH

Device Classification Information

Device Type ID133
Device NamePlethysmograph, Volume
Regulation DescriptionVolume Plethysmograph.
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 Number868.1760 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJEH
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 ID133
DevicePlethysmograph, Volume
Product CodeJEH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVolume Plethysmograph.
CFR Regulation Number868.1760 [🔎]
Device Problems
Thermal Decomposition Of Device
1
Melted
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:29:30

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