FDA 510(k)

iSR'obot 絲胞針組合包

K 號：K163502 · 2017-05-16

決定日期2017-05-16

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

iSR'obot Biopsy Kit 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 2017-05-16 under 510(k) number K163502. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iSR'obot Biopsy Kit?

iSR'obot Biopsy Kit is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K163502.

When did iSR'obot Biopsy Kit receive FDA 510(k) clearance?

iSR'obot Biopsy Kit received FDA 510(k) clearance on 2017-05-16, under 510(k) number K163502.

Who is the listed applicant for iSR'obot Biopsy Kit?

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 Biopsy Kit?

The FDA product code for iSR'obot Biopsy Kit is ITX.

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

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相關器械（代碼：ITX）

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官方來源

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