FDA 510(k)

手術計劃器（SRP）

K 號：K170793 · 2018-02-12

決定日期2018-02-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

SuRgical Planner (SRP) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, LLC. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K170793. 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 SuRgical Planner (SRP)?

SuRgical Planner (SRP) is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Surgical Theater, LLC. The 510(k) number is K170793.

When did SuRgical Planner (SRP) receive FDA 510(k) clearance?

SuRgical Planner (SRP) received FDA 510(k) clearance on 2018-02-12, under 510(k) number K170793.

Who is the listed applicant for SuRgical Planner (SRP)?

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

What is the FDA product code for SuRgical Planner (SRP)?

The FDA product code for SuRgical Planner (SRP) is LLZ.

其他以 Surgical Theater, LLC 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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