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FDA 510(k)

KONICAMINOLTA DI-X1

K号: K212685 · 2021-09-13

决定日期2021-09-13
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

KONICAMINOLTA DI-X1 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K212685. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KONICAMINOLTA DI-X1?

KONICAMINOLTA DI-X1 is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K212685.

When did KONICAMINOLTA DI-X1 receive FDA 510(k) clearance?

KONICAMINOLTA DI-X1 received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212685.

Who is the listed applicant for KONICAMINOLTA DI-X1?

The FDA 510(k) record lists Konica Minolta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KONICAMINOLTA DI-X1?

The FDA product code for KONICAMINOLTA DI-X1 is LLZ.

相关临床试验

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列明Konica Minolta, Inc.为申报人的其他记录

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相关器械(代码:LLZ)

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。

官方来源

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