DSB — Plethysmograph, Impedance Class II

FDA Device Classification

Classification Details

Product Code
DSB
Device Class
Class II
Regulation Number
870.2770
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250634fresenius medical care renal therapies groupBCM2-Body Composition MonitorNovember 24, 2025
K243727mode sensorsRe:BalansOctober 16, 2025
K250922cardioset medicalEdema Guard Monitor (EGM) CardioSet-001September 9, 2025
K232089impedimed limitedSOZO ProOctober 17, 2023
K223217zynex medicalZynex Monitoring System, Model CM-1600June 16, 2023
K211585bodyportBodyport Cardiac ScaleJuly 29, 2022
K203473impedimed limitedSOZOApril 19, 2021
K193410impedimed limitedSOZO Body Fluid AnalyzerOctober 2, 2020
K191697zynex medicalCardiac Monitor 1500February 21, 2020
K180479sensible medical innovationsReDS SystemFebruary 28, 2019
K172431physiowaveCardiovascular AnalzyerMarch 14, 2018
K172507impedimed limitedSOZODecember 22, 2017
K172196ecom medicalECOM™ Cardiac Output Monitoring SystemSeptember 19, 2017
K150095sensible medical innovationsReDs Wearable SystemAugust 6, 2015
K142503intersection medicalIMED-Z FLUID STATUS MONITORJune 5, 2015
K140102vasocomPHYSIOFLOW Q-LINKFebruary 12, 2014
K133301noninvasive medical technologiesZOE FLUID STATUS MONITORJanuary 22, 2014
K131765conmed corporationECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEMDecember 20, 2013
K131509noninvasive medical technologiesZOE FLUID STATUS MONITORJune 28, 2013
K112830noninvasive medical technologiesZOEFLUID STATUS MONITOR (MODEL ZOE 2B)November 13, 2012