Ballistocardiograph

Device Code: 825

Product Code(s): DXR

Device Classification Information

Device Type ID825
Device NameBallistocardiograph
Regulation DescriptionBallistocardiograph.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.2320 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDXR
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 ID825
DeviceBallistocardiograph
Product CodeDXR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBallistocardiograph.
CFR Regulation Number870.2320 [🔎]
TPLC Last Update: 2019-04-02 19:42:28

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