FDA 510(k)

ALADDIN HW3.0

K号: K160327 · 2016-10-05

决定日期2016-10-05

产品代码HJO

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决定实质等同

器械摘要

ALADDIN HW3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Visia Imaging S.R.L.. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K160327. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ALADDIN HW3.0?

ALADDIN HW3.0 is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Visia Imaging S.R.L.. The 510(k) number is K160327.

When did ALADDIN HW3.0 receive FDA 510(k) clearance?

ALADDIN HW3.0 received FDA 510(k) clearance on 2016-10-05, under 510(k) number K160327.

Who is the listed applicant for ALADDIN HW3.0?

The FDA 510(k) record lists Visia Imaging S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALADDIN HW3.0?

The FDA product code for ALADDIN HW3.0 is HJO.

列明Visia Imaging S.R.L.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。

K222933MYAH K211868MYAH

官方来源

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