印象材質
K 號：K201483 · 2020-10-08
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器材摘要
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.
常見問題
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.
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相關器械（代碼：ELW）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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