FDA 510(k)

IRIS 1.0 系統

K 號：K182643 · 2019-02-22

決定日期2019-02-22

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

IRIS 1.0 System is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K182643. 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 IRIS 1.0 System?

IRIS 1.0 System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Intuitive Surgical. The 510(k) number is K182643.

When did IRIS 1.0 System receive FDA 510(k) clearance?

IRIS 1.0 System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K182643.

Who is the listed applicant for IRIS 1.0 System?

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

What is the FDA product code for IRIS 1.0 System?

The FDA product code for IRIS 1.0 System is LLZ.

其他以 Intuitive Surgical 為申請人之記錄

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相關器械（代碼：LLZ）

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