Cleared Special

SOZO Pro

K230531 · ImpediMed Limited · Gastroenterology & Urology
May 2023
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K230531 is an FDA 510(k) clearance for the SOZO Pro, a Adjunct Monitor, Protein Calorie Malnutrition (Class II — Special Controls, product code QJB), submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on May 4, 2023, 66 days after receiving the submission on February 27, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K230531 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2023
Decision Date May 04, 2023
Days to Decision 66 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code QJB — Adjunct Monitor, Protein Calorie Malnutrition
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770
Definition Device Applies An Alternating Current Of One Specified Frequency Or More Through Skin-surface Electrodes To Estimate One Or More The Body Composition Parameters.