FDA 510(k)

Keffort (MC-100、MC-100A)

K 號：K213133 · 2022-04-13

決定日期2022-04-13

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Oriental Inspiration Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：KPI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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