FDA 510(k)

MAMMI

K号: K161631 · 2016-07-28

申请人General Equipment For Medical Imaging

决定日期2016-07-28

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

MAMMI is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161631. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAMMI?

MAMMI is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is General Equipment For Medical Imaging. The 510(k) number is K161631.

When did MAMMI receive FDA 510(k) clearance?

MAMMI received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161631.

Who is the listed applicant for MAMMI?

The FDA 510(k) record lists General Equipment For Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMI?

The FDA product code for MAMMI is KPS.

相关器械（代码：KPS）

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器械摘要

常见问题

相关临床试验

相关器械（代码：KPS）

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