SOZO Pro

FDA 510(k) K232089 · ImpediMed Limited

Substantially Equivalent

510(k) numberK232089

Submission

Device name
SOZO Pro
Applicant
ImpediMed Limited
Pinkenba, AU
Received
July 13, 2023
Decision date
October 17, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSB – Plethysmograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

Other 510(k)s with product code DSB

510(k)DeviceApplicantDecision
K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional ImpediMed Limited08/17/2026SE
K250634BCM2-Body Composition MonitorDSB · Traditional Fresenius Medical Care Renal Therapies Group, LLC11/24/2025SE
K243727Re:BalansDSB · Traditional Mode Sensors AS10/16/2025SE
K250922Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional Cardioset Medical , Ltd.09/09/2025SE
K223217Zynex Monitoring System, Model CM-1600DSB · Traditional Zynex Medical, Inc.06/16/2023SE
K211585Bodyport Cardiac ScaleDSB · Traditional Bodyport, Inc.07/29/2022SE
K203473SozoDSB · Traditional ImpediMed Limited04/19/2021SE
K193410SOZO Body Fluid AnalyzerDSB · Traditional ImpediMed Limited10/02/2020SE
K191697Cardiac Monitor 1500DSB · Traditional Zynex Medical, Inc.02/21/2020SE
K180479ReDS SystemDSB · Traditional Sensible Medical Innovations , Ltd.02/28/2019SE

More from Sensible Medical Innovations , Ltd.

510(k)DeviceDecision
K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional 08/17/2026SE
K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional 01/28/2026SE
K230531SOZO ProQJB · Special 05/04/2023SE
K230530SOZO ProOBH · Special 05/04/2023SE
K203473SozoDSB · Traditional 04/19/2021SE
K193410SOZO Body Fluid AnalyzerDSB · Traditional 10/02/2020SE
K190529SozoQJB · Traditional 11/25/2019SE
K180126SozoOBH · Traditional 04/16/2018SE
K172507SozoDSB · Traditional 12/22/2017SE
K172122SozoOBH · Special 08/11/2017SE

Questions and answers

When was SOZO Pro cleared by the FDA?

SOZO Pro (K232089) received a 510(k) decision of Substantially Equivalent on October 17, 2023, 96 days after the submission was received.

What is the product code of K232089?

The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.