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FDA 510(k)

Qraypen

K-Number: K183121 · 2019-07-18

ApplicantAIOBIO Co., Ltd.
Decision Date2019-07-18
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Qraypen is a medical device manufactured by AIOBIO Co., Ltd.. It received FDA 510(k) clearance on 2019-07-18 under approval number K183121. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qraypen?

Qraypen is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by AIOBIO Co., Ltd.. The 510(k) number is K183121.

When was Qraypen approved by the FDA?

Qraypen received FDA 510(k) clearance on 2019-07-18, under approval number K183121.

What company makes Qraypen?

Qraypen is manufactured by AIOBIO Co., Ltd..

What is the FDA product code for Qraypen?

The FDA product code for Qraypen is EIA.

Other Devices by AIOBIO Co., Ltd.

K221275Qraycam PRO

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Official Source

View on FDA Database →

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

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