FDA 510(k)

超/声扫描凝胶

K号: K163026 · 2018-01-09

决定日期2018-01-09

产品代码MUI

咨询委员会RA

决定实质等同

器械摘要

Ultra/Phonic Scanning Gel is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Innovations, Inc.. It received FDA 510(k) clearance on 2018-01-09 under 510(k) number K163026. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultra/Phonic Scanning Gel?

Ultra/Phonic Scanning Gel is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Pharmaceutical Innovations, Inc.. The 510(k) number is K163026.

When did Ultra/Phonic Scanning Gel receive FDA 510(k) clearance?

Ultra/Phonic Scanning Gel received FDA 510(k) clearance on 2018-01-09, under 510(k) number K163026.

Who is the listed applicant for Ultra/Phonic Scanning Gel?

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

What is the FDA product code for Ultra/Phonic Scanning Gel?

The FDA product code for Ultra/Phonic Scanning Gel is MUI.

列明Pharmaceutical Innovations, Inc.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。

K163027超/声导电凝胶 K163024超/声导电凝胶 K163023其他-声波传输凝胶

官方来源

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