FDA 510(k)

外科AR

K 號：K190764 · 2019-05-13

決定日期2019-05-13

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

SurgicalAR is the device name listed in this FDA 510(k) record. The listed applicant is Medivis, Inc.. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K190764. 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 SurgicalAR?

SurgicalAR is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is Medivis, Inc.. The 510(k) number is K190764.

When did SurgicalAR receive FDA 510(k) clearance?

SurgicalAR received FDA 510(k) clearance on 2019-05-13, under 510(k) number K190764.

Who is the listed applicant for SurgicalAR?

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

What is the FDA product code for SurgicalAR?

The FDA product code for SurgicalAR is LLZ.

其他以 Medivis, Inc. 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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