FDA 510(k)

IontoDC

K号: K170291 · 2017-05-01

决定日期2017-05-01

产品代码EGJ

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决定实质等同

器械摘要

IontoDC is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K170291. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IontoDC?

IontoDC is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K170291.

When did IontoDC receive FDA 510(k) clearance?

IontoDC received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170291.

Who is the listed applicant for IontoDC?

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

What is the FDA product code for IontoDC?

The FDA product code for IontoDC is EGJ.

列明Soterix Medical, 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。

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