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FDA 510(k)

WRDensity 由 Whiterabbit.ai 提供

K 號：K202013 · 2020-10-30

申請人Whiterabbit.Ai, Inc.
決定日期2020-10-30
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

WRDensity by Whiterabbit.ai is the device name listed in this FDA 510(k) record. The listed applicant is Whiterabbit.Ai, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K202013. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WRDensity by Whiterabbit.ai?

WRDensity by Whiterabbit.ai is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Whiterabbit.Ai, Inc.. The 510(k) number is K202013.

When did WRDensity by Whiterabbit.ai receive FDA 510(k) clearance?

WRDensity by Whiterabbit.ai received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202013.

Who is the listed applicant for WRDensity by Whiterabbit.ai?

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

What is the FDA product code for WRDensity by Whiterabbit.ai?

The FDA product code for WRDensity by Whiterabbit.ai is QIH.

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官方來源

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