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FDA 510(k)

easy Claire

K-Number: K213285 · 2022-03-03

ApplicantY & J Bio Co., Ltd.
Decision Date2022-03-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

easy Claire is the device name listed in this FDA 510(k) record. The listed applicant is Y & J Bio Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K213285. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the easy Claire?

easy Claire is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Y & J Bio Co., Ltd.. The 510(k) number is K213285.

When did easy Claire receive FDA 510(k) clearance?

easy Claire received FDA 510(k) clearance on 2022-03-03, under 510(k) number K213285.

Who is the listed applicant for easy Claire?

The FDA 510(k) record lists Y & J Bio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for easy Claire?

The FDA product code for easy Claire is OHS.

Other records listing Y & J Bio 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.

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Related Devices (Code: OHS)

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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.

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