Cleared Traditional

SOZO

K172507 · ImpediMed Limited · Cardiovascular
Dec 2017
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K172507 is an FDA 510(k) clearance for the SOZO, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on December 22, 2017, 126 days after receiving the submission on August 18, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K172507 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2017
Decision Date December 22, 2017
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770