Cardiograph, Apex (vibrocardiograph)

Device Code: 734

Product Code(s): DQH

Device Classification Information

Device Type ID734
Device NameCardiograph, Apex (vibrocardiograph)
Regulation DescriptionApex Cardiograph (vibrocardiograph).
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 Number870.2310 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDQH
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 ID734
DeviceCardiograph, Apex (vibrocardiograph)
Product CodeDQH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionApex Cardiograph (vibrocardiograph).
CFR Regulation Number870.2310 [🔎]
TPLC Last Update: 2019-04-02 19:39:56

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