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FDA 510(k)

CLINICARD CK-II

K-Number: K772258 · 1978-01-05

ApplicantHarleco
Decision Date1978-01-05
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICARD CK-II is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1978-01-05 under 510(k) number K772258. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICARD CK-II?

CLINICARD CK-II is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Harleco. The 510(k) number is K772258.

When did CLINICARD CK-II receive FDA 510(k) clearance?

CLINICARD CK-II received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772258.

Who is the listed applicant for CLINICARD CK-II?

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

What is the FDA product code for CLINICARD CK-II?

The FDA product code for CLINICARD CK-II is CGS.

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Other records listing Harleco 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.

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Related Devices (Code: CGS)

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.

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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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