FDA 510(k)

外科控制手臂

K 號：K223673 · 2023-08-04

決定日期2023-08-04

產品代碼PNL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Surgeon Controlled Arm is the device name listed in this FDA 510(k) record. The listed applicant is Levita Magnetics International Corp. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K223673. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgeon Controlled Arm?

Surgeon Controlled Arm is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Levita Magnetics International Corp. The 510(k) number is K223673.

When did Surgeon Controlled Arm receive FDA 510(k) clearance?

Surgeon Controlled Arm received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223673.

Who is the listed applicant for Surgeon Controlled Arm?

The FDA 510(k) record lists Levita Magnetics International Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgeon Controlled Arm?

The FDA product code for Surgeon Controlled Arm is PNL.

其他以 Levita Magnetics International Corp 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。

K252435磁力外科系統 K250746磁力外科系統 K191762磁力外科系統 K190006磁力外科系統 K180894磁力外科系統 K171429磁力外科系統

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相關器械（代碼：PNL）

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。

K252435磁力外科系統Levita Magnetics International Corp K250746磁力外科系統Levita Magnetics International Corp K191762磁力外科系統Levita Magnetics International Corp K190006磁力外科系統Levita Magnetics International Corp K180894磁力外科系統Levita Magnetics International Corp K171429磁力外科系統Levita Magnetics International Corp

官方來源

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