Adaptor, Lead Switching, Electrocardiograph

Device Code: 760

Product Code(s): DRW

Device Classification Information

Device Type ID760
Device NameAdaptor, Lead Switching, Electrocardiograph
Regulation DescriptionElectrocardiograph Lead Switching Adaptor.
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 Number870.2350 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDRW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID760
DeviceAdaptor, Lead Switching, Electrocardiograph
Product CodeDRW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrocardiograph Lead Switching Adaptor.
CFR Regulation Number870.2350 [🔎]
TPLC Last Update: 2019-04-02 19:40:45

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