Plethysmograph, Pressure

Device Code: 116

Product Code(s): CCM

Device Classification Information

Device Type ID116
Device NamePlethysmograph, Pressure
Regulation DescriptionPressure 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 Number868.1750 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCCM
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 ID116
DevicePlethysmograph, Pressure
Product CodeCCM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPressure Plethysmograph.
CFR Regulation Number868.1750 [🔎]
Device Problems
Device Displays Incorrect Message
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 19:29:16

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