Cleared Special

SOZO

K172122 · ImpediMed Limited · Gastroenterology & Urology

Aug 2017

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K172122 is an FDA 510(k) clearance for the SOZO, a Monitor, Extracellular Fluid, Lymphedema, Extremity (Class II — Special Controls, product code OBH), submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on August 11, 2017, 29 days after receiving the submission on July 13, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number	K172122 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2017
Decision Date	August 11, 2017
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OBH — Monitor, Extracellular Fluid, Lymphedema, Extremity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2770
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)