FDA 510(k)

Amber Mill Q Series & Amber Mill Direct Series

K 號：K202952 · 2021-08-26

決定日期2021-08-26

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Amber Mill Q Series & Amber Mill Direct Series is the device name listed in this FDA 510(k) record. The listed applicant is Hass Corp.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K202952. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Amber Mill Q Series & Amber Mill Direct Series?

Amber Mill Q Series & Amber Mill Direct Series is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Hass Corp.. The 510(k) number is K202952.

When did Amber Mill Q Series & Amber Mill Direct Series receive FDA 510(k) clearance?

Amber Mill Q Series & Amber Mill Direct Series received FDA 510(k) clearance on 2021-08-26, under 510(k) number K202952.

Who is the listed applicant for Amber Mill Q Series & Amber Mill Direct Series?

The FDA 510(k) record lists Hass Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amber Mill Q Series & Amber Mill Direct Series?

The FDA product code for Amber Mill Q Series & Amber Mill Direct Series is EIH.

其他以 Hass Corp. 為申請人之記錄

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。

K260859羅塞塔SM，羅塞塔SP K160102Amber Mill Series and Amber Press Series

相關器械（代碼：EIH）

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。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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