Cheetah Reliant, Cheetah Active

FDA 510(k) K072662 · Cheetah Medical, Inc.

Substantially Equivalent

510(k) numberK072662

Submission

Device name
Cheetah Reliant, Cheetah Active
Applicant
Cheetah Medical, Inc.
Mizpe Aviv, M.P. Misgav, IL
Received
September 21, 2007
Decision date
January 16, 2008
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

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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
K083093Cheetah ReliantDSB · Abbreviated 12/15/2008SE
K071631Nicom ElectrodesDXG · Traditional 01/18/2008SE
K042144NicomDXG · Traditional 11/12/2004SE
K023370Cheetah I.V.D.S., Model 2002PDQK · Traditional 12/24/2002SE

Questions and answers

When was Cheetah Reliant, Cheetah Active cleared by the FDA?

Cheetah Reliant, Cheetah Active (K072662) received a 510(k) decision of Substantially Equivalent on January 16, 2008, 117 days after the submission was received.

What is the product code of K072662?

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