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Monitor, Extracellular Fluid, Lymphedema, Extremity

FDA product code OBH · 9 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2770
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-03-30 – 2026-01-28

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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