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OBHClass II

Monitor, Extracellular Fluid, Lymphedema, Extremity

21 CFR 870.2770 / Cardiovascular

OBH is the FDA product code for Monitor, Extracellular Fluid, Lymphedema, Extremity, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "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)". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OBH
Device name
Monitor, Extracellular Fluid, Lymphedema, Extremity
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)
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
1

Clearances, product code OBH

By decision year
10 clearances under product code OBH with a decision year between 2007 and 2026, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBH by decision year
YearClearances
20071
20081
20111
20131
20151
20171
20181
20221
20231
20261

Applicants with the most clearances

Product code OBH
Applicants holding the most 510(k) clearances under product code OBH
ApplicantClearances
Impedimed, Inc.8
Delfin Technologies Ltd2

Companies listing this code with FDA

Companies whose registered establishments list this code