FDA 510(k)

SOMNUM (V.1.1.2.)

K号: K223922 · 2023-08-16

决定日期2023-08-16

产品代码OLZ

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决定实质等同

器械摘要

SOMNUM (V.1.1.2.) is the device name listed in this FDA 510(k) record. The listed applicant is Honeynaps Co., Ltd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223922. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SOMNUM (V.1.1.2.)?

SOMNUM (V.1.1.2.) is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Honeynaps Co., Ltd.. The 510(k) number is K223922.

When did SOMNUM (V.1.1.2.) receive FDA 510(k) clearance?

SOMNUM (V.1.1.2.) received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223922.

Who is the listed applicant for SOMNUM (V.1.1.2.)?

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

What is the FDA product code for SOMNUM (V.1.1.2.)?

The FDA product code for SOMNUM (V.1.1.2.) is OLZ.

列明Honeynaps Co., Ltd.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。

K253390SOMNUM (SOMNUM)

官方来源

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