FDA 510(k)

Pulmogine Vibrating Mesh Nebulizer

K-Number: K202171 · 2021-07-01

Decision Date2021-07-01

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Pulmogine Vibrating Mesh Nebulizer is a medical device manufactured by Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2021-07-01 under approval number K202171. 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 Pulmogine Vibrating Mesh Nebulizer?

Pulmogine Vibrating Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by Hcmed Innovations Co., Ltd.. The 510(k) number is K202171.

When was Pulmogine Vibrating Mesh Nebulizer approved by the FDA?

Pulmogine Vibrating Mesh Nebulizer received FDA 510(k) clearance on 2021-07-01, under approval number K202171.

What company makes Pulmogine Vibrating Mesh Nebulizer?

Pulmogine Vibrating Mesh Nebulizer is manufactured by Hcmed Innovations Co., Ltd..

What is the FDA product code for Pulmogine Vibrating Mesh Nebulizer?

The FDA product code for Pulmogine Vibrating Mesh Nebulizer is CAF.

Other Devices by Hcmed Innovations Co., Ltd.

K250583AdheResp Smart Breath-actuated Mesh Nebulizer

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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.