Cheetah Reliant

FDA 510(k) K083093 · Cheetah Medical, Inc.

Substantially Equivalent

510(k) numberK083093

Submission

Device name
Cheetah Reliant
Applicant
Cheetah Medical, Inc.
Gaithersburg, MD, US
Received
October 17, 2008
Decision date
December 15, 2008
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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

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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
K103166Cheetah ReliantDSB · Abbreviated 01/25/2011SE
K101487Cheetah Nicom SystemDXG · Abbreviated 07/02/2010SE
K071631Nicom ElectrodesDXG · Traditional 01/18/2008SE
K072662Cheetah Reliant, Cheetah ActiveDSB · Traditional 01/16/2008SE
K042144NicomDXG · Traditional 11/12/2004SE
K023370Cheetah I.V.D.S., Model 2002PDQK · Traditional 12/24/2002SE

Questions and answers

When was Cheetah Reliant cleared by the FDA?

Cheetah Reliant (K083093) received a 510(k) decision of Substantially Equivalent on December 15, 2008, 59 days after the submission was received.

What is the product code of K083093?

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