FDA 510(k)

AMADEO, M-UK1015 (含附件和配件)

K 號：K213221 · 2022-05-26

決定日期2022-05-26

產品代碼ERL

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

AMADEO, M-UK1015 (incl. attachments and accessories) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoss GmbH. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K213221. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMADEO, M-UK1015 (incl. attachments and accessories)?

AMADEO, M-UK1015 (incl. attachments and accessories) is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is W&H Dentalwerk Buermoss GmbH. The 510(k) number is K213221.

When did AMADEO, M-UK1015 (incl. attachments and accessories) receive FDA 510(k) clearance?

AMADEO, M-UK1015 (incl. attachments and accessories) received FDA 510(k) clearance on 2022-05-26, under 510(k) number K213221.

Who is the listed applicant for AMADEO, M-UK1015 (incl. attachments and accessories)?

The FDA 510(k) record lists W&H Dentalwerk Buermoss GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories)?

The FDA product code for AMADEO, M-UK1015 (incl. attachments and accessories) is ERL.

其他以 W&H Dentalwerk Buermoss GmbH 為申請人之記錄

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相關器械（代碼：ERL）

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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