Recorder, External, Pressure, Amplifier & Transducer

Device Code: 1793

Product Code(s): FES

Device Classification Information

Device Type ID1793
Device NameRecorder, External, Pressure, Amplifier & Transducer
Regulation DescriptionGastrointestinal Motility Monitoring System.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(k)
CFR Regulation Number876.1725 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFES
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 ID1793
DeviceRecorder, External, Pressure, Amplifier & Transducer
Product CodeFES
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Motility Monitoring System.
CFR Regulation Number876.1725 [🔎]
TPLC Last Update: 2019-04-02 19:59:42

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