Ultrasonic Body Composition Analyzer

Product Code: OMV

Cardiovascular Diagnostic Ultrasound Devices

Definition: Intended To Measure Thickness Of A Distinctive Tissue Layer. Indicated To Calculate The Local Thickness Of A Type Of Tissue [fat, Muscle, Bone, Etc. ] At A Single Location, Or At Various Locations On The Body And Via Algorithms, Estimate The Amount Of Local Tissue Or Total Body Tissue, Respectively.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2770


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as OMV

1671Ultrasonic Body Composition AnalyzerImpedance Plethysmograph.

Total Product Life Cycle (TPLC) Devices

1671Ultrasonic Body Composition AnalyzerImpedance Plethysmograph.

Pre-market Notifications for OMV

K082147BODYMETRIX BX2000INTELAMETRIX, INC

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