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FDA 510(k)

Nebulizer

K-Number: K212395 · 2022-03-25

Decision Date2022-03-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nebulizer is a medical device manufactured by Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-25 under approval number K212395. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nebulizer?

Nebulizer is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K212395.

When was Nebulizer approved by the FDA?

Nebulizer received FDA 510(k) clearance on 2022-03-25, under approval number K212395.

What company makes Nebulizer?

Nebulizer is manufactured by Shenzhen Homed Medical Device Co., Ltd..

What is the FDA product code for Nebulizer?

The FDA product code for Nebulizer is CAF.

Other Devices by Shenzhen Homed Medical Device Co., Ltd.

Related Devices (Code: CAF)

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.