FDA 510(k)

牙科感測器 NanoPix1，NanoPix2

K 號：K220422 · 2022-03-11

決定日期2022-03-11

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

Dental sensors NanoPix1, NanoPix2 is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K220422. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental sensors NanoPix1, NanoPix2?

Dental sensors NanoPix1, NanoPix2 is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K220422.

When did Dental sensors NanoPix1, NanoPix2 receive FDA 510(k) clearance?

Dental sensors NanoPix1, NanoPix2 received FDA 510(k) clearance on 2022-03-11, under 510(k) number K220422.

Who is the listed applicant for Dental sensors NanoPix1, NanoPix2?

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

What is the FDA product code for Dental sensors NanoPix1, NanoPix2?

The FDA product code for Dental sensors NanoPix1, NanoPix2 is MUH.

其他以 Iray Technology Taicang , Ltd. 為申請人之記錄

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相關器械（代碼：MUH）

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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官方來源

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