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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou Huaer Electro Optics Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) 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. The listed applicant is Zhengzhou Huaer Electro Optics Technology Co., Ltd.. The 510(k) number is K201483.

When did Impression Material receive FDA 510(k) clearance?

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

Who is the listed applicant for Impression Material?

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

What is the FDA product code for Impression Material?

The FDA product code for Impression Material is ELW.

Related Devices (Code: ELW)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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