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FDA 510(k)

Ultrasonic Mesh Nebulizer

K-Number: K201397 · 2021-06-14

ApplicantShenzhen Ivankaca Technology Co., Ltd.
Decision Date2021-06-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Mesh Nebulizer is a medical device manufactured by Shenzhen Ivankaca Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-14 under approval number K201397. 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 Ultrasonic Mesh Nebulizer?

Ultrasonic Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2021-06-14. It is manufactured by Shenzhen Ivankaca Technology Co., Ltd.. The 510(k) number is K201397.

When was Ultrasonic Mesh Nebulizer approved by the FDA?

Ultrasonic Mesh Nebulizer received FDA 510(k) clearance on 2021-06-14, under approval number K201397.

What company makes Ultrasonic Mesh Nebulizer?

Ultrasonic Mesh Nebulizer is manufactured by Shenzhen Ivankaca Technology Co., Ltd..

What is the FDA product code for Ultrasonic Mesh Nebulizer?

The FDA product code for Ultrasonic Mesh Nebulizer is CAF.

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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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