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FDA 510(k)

Qraycam PRO

K-Number: K221275 · 2024-09-04

Decision Date2024-09-04
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Qraycam PRO?

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

When was Qraycam PRO approved by the FDA?

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

What company makes Qraycam PRO?

Qraycam PRO is manufactured by AIOBIO Co., Ltd..

What is the FDA product code for Qraycam PRO?

The FDA product code for Qraycam PRO is NBL.

Other Devices by AIOBIO Co., Ltd.

Related Devices (Code: NBL)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.