FDA 510(k)

HYPNOSPAD

K号: K152660 · 2016-11-09

决定日期2016-11-09

产品代码LRK

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决定实质等同

器械摘要

HYPNOSPAD is the device name listed in this FDA 510(k) record. The listed applicant is Somnics, Inc.. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K152660. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HYPNOSPAD?

HYPNOSPAD is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Somnics, Inc.. The 510(k) number is K152660.

When did HYPNOSPAD receive FDA 510(k) clearance?

HYPNOSPAD received FDA 510(k) clearance on 2016-11-09, under 510(k) number K152660.

Who is the listed applicant for HYPNOSPAD?

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

What is the FDA product code for HYPNOSPAD?

The FDA product code for HYPNOSPAD is LRK.

列明Somnics, 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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