FDA 510(k)

Keffort (MC-100, MC-100A)

K番号: K213133 · 2022-04-13

決定日2022-04-13

製品コードKPI

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

Keffort (MC-100, MC-100A) is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K213133. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Keffort (MC-100, MC-100A)?

Keffort (MC-100, MC-100A) is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K213133.

When did Keffort (MC-100, MC-100A) receive FDA 510(k) clearance?

Keffort (MC-100, MC-100A) received FDA 510(k) clearance on 2022-04-13, under 510(k) number K213133.

Who is the listed applicant for Keffort (MC-100, MC-100A)?

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

What is the FDA product code for Keffort (MC-100, MC-100A)?

The FDA product code for Keffort (MC-100, MC-100A) is KPI.

申請者としてOriental Inspiration Limitedを記載するその他の記録

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公式ソース

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