Phonocardiograph

Device Code: 730

Product Code(s): DQC

Device Classification Information

Device Type ID730
Device NamePhonocardiograph
Regulation DescriptionPhonocardiograph.
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) Exempt
CFR Regulation Number870.2390 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDQC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID730
DevicePhonocardiograph
Product CodeDQC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPhonocardiograph.
CFR Regulation Number870.2390 [🔎]
TPLC Last Update: 2019-04-02 19:39:53

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