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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ivankaca Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-14 under 510(k) 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. The listed applicant is Shenzhen Ivankaca Technology Co., Ltd.. The 510(k) number is K201397.

When did Ultrasonic Mesh Nebulizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasonic Mesh Nebulizer?

The FDA 510(k) record lists Shenzhen Ivankaca Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Mesh Nebulizer?

The FDA product code for Ultrasonic Mesh Nebulizer is CAF.

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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