OBH

10 FDA 510(k) clearances · Product code

FDA profile

Official device name

Monitor, Extracellular Fluid, Lymphedema, Extremity

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2770

Medical specialty

Cardiovascular

FDA definition

Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

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