FDA 510(k)

AcuPebble SA

K 號：K210480 · 2021-07-06

決定日期2021-07-06

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

AcuPebble SA is the device name listed in this FDA 510(k) record. The listed applicant is Acurable Limited. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K210480. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AcuPebble SA?

AcuPebble SA is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is Acurable Limited. The 510(k) number is K210480.

When did AcuPebble SA receive FDA 510(k) clearance?

AcuPebble SA received FDA 510(k) clearance on 2021-07-06, under 510(k) number K210480.

Who is the listed applicant for AcuPebble SA?

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

What is the FDA product code for AcuPebble SA?

The FDA product code for AcuPebble SA is MNR.

其他以 Acurable 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：MNR）

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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