FDA 510(k)

AIK単回使用用無菌鍼

K番号: K162566 · 2017-05-11

申請者Changchun Aik Medical Devices Co., Ltd.

決定日2017-05-11

製品コードMQX

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

AIK Sterile Acupuncture Needles for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Changchun Aik Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K162566. The device is classified under product code MQX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AIK Sterile Acupuncture Needles for Single Use?

AIK Sterile Acupuncture Needles for Single Use is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Changchun Aik Medical Devices Co., Ltd.. The 510(k) number is K162566.

When did AIK Sterile Acupuncture Needles for Single Use receive FDA 510(k) clearance?

AIK Sterile Acupuncture Needles for Single Use received FDA 510(k) clearance on 2017-05-11, under 510(k) number K162566.

Who is the listed applicant for AIK Sterile Acupuncture Needles for Single Use?

The FDA 510(k) record lists Changchun Aik Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIK Sterile Acupuncture Needles for Single Use?

The FDA product code for AIK Sterile Acupuncture Needles for Single Use is MQX.

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医療機器の概要

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