FDA 510(k)

Ez正骨科

K 號：K192888 · 2020-03-13

決定日期2020-03-13

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

EzOrtho is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K192888. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzOrtho?

EzOrtho is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K192888.

When did EzOrtho receive FDA 510(k) clearance?

EzOrtho received FDA 510(k) clearance on 2020-03-13, under 510(k) number K192888.

Who is the listed applicant for EzOrtho?

The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EzOrtho?

The FDA product code for EzOrtho is LLZ.

其他以 Ewoosoft Co., Ltd. 為申請人之記錄

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相關器械（代碼：LLZ）

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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