Vectorcardiograph

Device Code: 833

Product Code(s): DYC

Device Classification Information

Device Type ID833
Device NameVectorcardiograph
Regulation DescriptionVectorcardiograph.
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 Number870.2400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDYC
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 ID833
DeviceVectorcardiograph
Product CodeDYC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVectorcardiograph.
CFR Regulation Number870.2400 [🔎]
TPLC Last Update: 2019-04-02 19:42:41

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