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FDA 510(k)

Impression Material

K-Number: K201483 · 2020-10-08

ApplicantZhengzhou Huaer Electro Optics Technology Co., Ltd.
Decision Date2020-10-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Impression Material is a medical device manufactured by Zhengzhou Huaer Electro Optics Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-08 under approval number K201483. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Impression Material?

Impression Material is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Zhengzhou Huaer Electro Optics Technology Co., Ltd.. The 510(k) number is K201483.

When was Impression Material approved by the FDA?

Impression Material received FDA 510(k) clearance on 2020-10-08, under approval number K201483.

What company makes Impression Material?

Impression Material is manufactured by Zhengzhou Huaer Electro Optics Technology Co., Ltd..

What is the FDA product code for Impression Material?

The FDA product code for Impression Material is ELW.

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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.

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