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FDA 510(k)

SERIES 602 CKG RECORDER (MODIFIED)

K-Number: K801485 · 1980-07-08

ApplicantCardio Kinetics, Inc.
Decision Date1980-07-08
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SERIES 602 CKG RECORDER (MODIFIED) 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 1980-07-08 under 510(k) number K801485. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 602 CKG RECORDER (MODIFIED)?

SERIES 602 CKG RECORDER (MODIFIED) is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Cardio Kinetics, Inc.. The 510(k) number is K801485.

When did SERIES 602 CKG RECORDER (MODIFIED) receive FDA 510(k) clearance?

SERIES 602 CKG RECORDER (MODIFIED) received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801485.

Who is the listed applicant for SERIES 602 CKG RECORDER (MODIFIED)?

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 SERIES 602 CKG RECORDER (MODIFIED)?

The FDA product code for SERIES 602 CKG RECORDER (MODIFIED) is DSF.

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 8000K800851SERIES 602 CKGTM RECORDERK792051CKG CARDIOKYMOGRAPH

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel 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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