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FDA 510(k)

CKG CARDIOKYMOGRAPH

K-Number: K792051 · 1979-11-13

ApplicantCardio Kinetics, Inc.
Decision Date1979-11-13
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CKG CARDIOKYMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Kinetics, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792051. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CKG CARDIOKYMOGRAPH?

CKG CARDIOKYMOGRAPH is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Cardio Kinetics, Inc.. The 510(k) number is K792051.

When did CKG CARDIOKYMOGRAPH receive FDA 510(k) clearance?

CKG CARDIOKYMOGRAPH received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792051.

Who is the listed applicant for CKG CARDIOKYMOGRAPH?

The FDA 510(k) record lists Cardio Kinetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CKG CARDIOKYMOGRAPH?

The FDA product code for CKG CARDIOKYMOGRAPH is DSB.

Related Clinical Trials

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Other records listing Cardio Kinetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K823215CKG 8800K822020CKG 8000K801485SERIES 602 CKG RECORDER (MODIFIED)K800851SERIES 602 CKGTM RECORDER

Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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