FDA 510(k)

Amber Mill Q 系列 & Amber Mill Direct 系列

K号: K202952 · 2021-08-26

决定日期2021-08-26

产品代码EIH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Hass Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260859Rosetta SM，Rosetta SP K160102Amber Mill 系列和 Amber 压缩机系列

官方来源

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