Densitometer

Device Code: 820

Product Code(s): DXM

Device Classification Information

Device Type ID820
Device NameDensitometer
Regulation DescriptionDensitometer.
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 Number870.1450 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDXM
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 ID820
DeviceDensitometer
Product CodeDXM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDensitometer.
CFR Regulation Number870.1450 [🔎]
TPLC Last Update: 2019-04-02 19:42:23

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