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FDA 510(k)

Hygenix

K-Number: K232797 · 2023-12-11

ApplicantShenzhen Hygenix Industrial Co., Ltd.
Decision Date2023-12-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hygenix is a medical device manufactured by Shenzhen Hygenix Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under approval number K232797. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hygenix?

Hygenix is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Shenzhen Hygenix Industrial Co., Ltd.. The 510(k) number is K232797.

When was Hygenix approved by the FDA?

Hygenix received FDA 510(k) clearance on 2023-12-11, under approval number K232797.

What company makes Hygenix?

Hygenix is manufactured by Shenzhen Hygenix Industrial Co., Ltd..

What is the FDA product code for Hygenix?

The FDA product code for Hygenix is FXX.

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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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