CKG 8000

FDA 510(k) K822020 · Cardio Kinetics, Inc.

Substantially Equivalent

510(k) numberK822020

Submission

Device name
CKG 8000
Applicant
Cardio Kinetics, Inc.
Mchenry, IL, US
Received
July 9, 1982
Decision date
August 6, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K823215CKG 8800DSB · Traditional 11/24/1982SE
K801485Series 602 CKG Recorder (Modified)DSF · Traditional 07/08/1980SE
K800851Series 602 Ckgtm RecorderDSF · Traditional 04/24/1980SE
K792051CKG CardiokymographDSB · Traditional 11/13/1979SE

Questions and answers

When was CKG 8000 cleared by the FDA?

CKG 8000 (K822020) received a 510(k) decision of Substantially Equivalent on August 6, 1982, 28 days after the submission was received.

What is the product code of K822020?

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