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Parker Quality & Compliance

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510(k) clearance

LymphaTech Mobile 3D Measuring Tool

FDA 510(k) source

510(k) number
K261628
Applicant
Lymphatech, Inc.
Decision date
Oct 28, 2026
Date received
May 15, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
OBH
Device type
Monitor, Extracellular Fluid, Lymphedema, Extremity
Device class
Class II
Regulation
21 CFR 870.2770
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Atlanta, GA, US