Zoe Fluid Status Monitor

FDA 510(k) K131509 · Noninvasive Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK131509

Submission

Device name
Zoe Fluid Status Monitor
Applicant
Noninvasive Medical Technologies, Inc.
Las Vegas, NV, US
Received
May 24, 2013
Decision date
June 28, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 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
K232089SOZO ProDSB · Traditional ImpediMed Limited10/17/2023SE
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

More from Zynex Medical, Inc.

510(k)DeviceDecision
K133301Zoe Fluid Status MonitorDSB · Special 01/22/2014SE
K112830Zoefluid Status Monitor (Model Zoe 2B)DSB · Traditional 11/13/2012SE
K042113Zoe Fluid Status MonitorDSB · Special 09/14/2004SE

Questions and answers

When was Zoe Fluid Status Monitor cleared by the FDA?

Zoe Fluid Status Monitor (K131509) received a 510(k) decision of Substantially Equivalent on June 28, 2013, 35 days after the submission was received.

What is the product code of K131509?

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