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FDA 510(k)

EUKARE

K-Number: K062892 · 2007-01-22

ApplicantEumed Biotechnology Co., Ltd.
Decision Date2007-01-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EUKARE is the device name listed in this FDA 510(k) record. The listed applicant is Eumed Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2007-01-22 under 510(k) number K062892. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUKARE?

EUKARE is a medical device that received FDA 510(k) clearance on 2007-01-22. The listed applicant is Eumed Biotechnology Co., Ltd.. The 510(k) number is K062892.

When did EUKARE receive FDA 510(k) clearance?

EUKARE received FDA 510(k) clearance on 2007-01-22, under 510(k) number K062892.

Who is the listed applicant for EUKARE?

The FDA 510(k) record lists Eumed Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUKARE?

The FDA product code for EUKARE is CGA.

Related Clinical Trials

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Other records listing Eumed Biotechnology Co., Ltd. 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.

K040678EUSURE BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: CGA)

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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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