FDA 510(k)

Filter and HME/Filter

K-Number: K221472 · 2023-02-08

ApplicantNingbo Huakun Medical Equipment Co., Ltd.

Decision Date2023-02-08

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Filter and HME/Filter is a medical device manufactured by Ningbo Huakun Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under approval number K221472. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Filter and HME/Filter?

Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2023-02-08. It is manufactured by Ningbo Huakun Medical Equipment Co., Ltd.. The 510(k) number is K221472.

When was Filter and HME/Filter approved by the FDA?

Filter and HME/Filter received FDA 510(k) clearance on 2023-02-08, under approval number K221472.

What company makes Filter and HME/Filter?

Filter and HME/Filter is manufactured by Ningbo Huakun Medical Equipment Co., Ltd..

What is the FDA product code for Filter and HME/Filter?

The FDA product code for Filter and HME/Filter is CAH.

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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.