FDA 510(k)

CKG 8000

K-Number: K822020 · 1982-08-06

Decision Date1982-08-06

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CKG 8000 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 1982-08-06 under 510(k) number K822020. 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 8000?

CKG 8000 is a medical device that received FDA 510(k) clearance on 1982-08-06. The listed applicant is Cardio Kinetics, Inc.. The 510(k) number is K822020.

When did CKG 8000 receive FDA 510(k) clearance?

CKG 8000 received FDA 510(k) clearance on 1982-08-06, under 510(k) number K822020.

Who is the listed applicant for CKG 8000?

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 8000?

The FDA product code for CKG 8000 is DSB.

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 8800 K801485SERIES 602 CKG RECORDER (MODIFIED)K800851SERIES 602 CKGTM RECORDER K792051CKG CARDIOKYMOGRAPH

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Official Source

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