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FDA 510(k)

Surgivisio系统

K号: K202547 · 2021-03-26

申请人Surgivisio
决定日期2021-03-26
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

Surgivisio system is the device name listed in this FDA 510(k) record. The listed applicant is Surgivisio. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K202547. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Surgivisio system?

Surgivisio system is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Surgivisio. The 510(k) number is K202547.

When did Surgivisio system receive FDA 510(k) clearance?

Surgivisio system received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202547.

Who is the listed applicant for Surgivisio system?

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

What is the FDA product code for Surgivisio system?

The FDA product code for Surgivisio system is OWB.

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相关器械(代码:OWB)

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