FDA 510(k)

iSR’obot 蒙娜麗莎 2.0

K 號：K213411 · 2021-12-22

決定日期2021-12-22

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

iSR’obot Mona Lisa 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213411. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iSR’obot Mona Lisa 2.0?

iSR’obot Mona Lisa 2.0 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K213411.

When did iSR’obot Mona Lisa 2.0 receive FDA 510(k) clearance?

iSR’obot Mona Lisa 2.0 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213411.

Who is the listed applicant for iSR’obot Mona Lisa 2.0?

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

What is the FDA product code for iSR’obot Mona Lisa 2.0?

The FDA product code for iSR’obot Mona Lisa 2.0 is IYO.

其他以 Biobot Surgical Pte., Ltd. 為申請人之記錄

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官方來源

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