FDA 510(k)

Hura CTP v1.0

K 號：K212550 · 2021-11-08

決定日期2021-11-08

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Hura CTP v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hura Imaging, Inc.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212550. 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 Hura CTP v1.0?

Hura CTP v1.0 is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Hura Imaging, Inc.. The 510(k) number is K212550.

When did Hura CTP v1.0 receive FDA 510(k) clearance?

Hura CTP v1.0 received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212550.

Who is the listed applicant for Hura CTP v1.0?

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

What is the FDA product code for Hura CTP v1.0?

The FDA product code for Hura CTP v1.0 is LLZ.

相關器械（代碼：LLZ）

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