FDA product code OBH

Monitor, Extracellular Fluid, Lymphedema, Extremity

Cardiovascular·Class 2·21 CFR 870.2770
US regulatory classifications
US Product Code (FDA)
OBH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2770
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Monitor, Extracellular Fluid, Lymphedema, Extremity is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.