FDA 510(k)

Qraycam PRO

K 號：K221275 · 2024-09-04

決定日期2024-09-04

產品代碼NBL

諮詢委員會DE

決定相當於

器材摘要

Qraycam PRO is the device name listed in this FDA 510(k) record. The listed applicant is AIOBIO Co., Ltd.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K221275. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Qraycam PRO?

Qraycam PRO is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is AIOBIO Co., Ltd.. The 510(k) number is K221275.

When did Qraycam PRO receive FDA 510(k) clearance?

Qraycam PRO received FDA 510(k) clearance on 2024-09-04, under 510(k) number K221275.

Who is the listed applicant for Qraycam PRO?

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

What is the FDA product code for Qraycam PRO?

The FDA product code for Qraycam PRO is NBL.

其他以 AIOBIO Co., Ltd. 為申請人之記錄

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K183121Qraypen

相關器械（代碼：NBL）

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官方來源

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