FDA 510(k)

RIGHTEST ランシングデバイス GD500、GE ランシングデバイス、iGlucose ランシングデバイス

K番号: K221062 · 2022-09-26

決定日2022-09-26

製品コードQRL

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K221062. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Bionime Corporation. The 510(k) number is K221062.

When did RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device receive FDA 510(k) clearance?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device received FDA 510(k) clearance on 2022-09-26, under 510(k) number K221062.

Who is the listed applicant for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

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

What is the FDA product code for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

The FDA product code for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is QRL.

申請者としてBionime Corporationを記載するその他の記録

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公式ソース

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