Monitor, Spinal-fluid Pressure, Electrically Powered

Device Code: 2535

Product Code(s): CAR

Device Classification Information

Device Type ID2535
Device NameMonitor, Spinal-fluid Pressure, Electrically Powered
Regulation DescriptionElectrically Powered Spinal Fluid Pressure Monitor.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number880.2460 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCAR
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 ID2535
DeviceMonitor, Spinal-fluid Pressure, Electrically Powered
Product CodeCAR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrically Powered Spinal Fluid Pressure Monitor.
CFR Regulation Number880.2460 [🔎]
TPLC Last Update: 2019-04-02 20:13:54

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