FDA 510(k)

iNAP One睡眠治疗系统。

K号: K220907 · 2023-06-16

决定日期2023-06-16

产品代码OZR

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决定实质等同

器械摘要

The iNAP One Sleep Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Somnics, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K220907. The device is classified under product code OZR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The iNAP One Sleep Therapy System?

The iNAP One Sleep Therapy System is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Somnics, Inc.. The 510(k) number is K220907.

When did The iNAP One Sleep Therapy System receive FDA 510(k) clearance?

The iNAP One Sleep Therapy System received FDA 510(k) clearance on 2023-06-16, under 510(k) number K220907.

Who is the listed applicant for The iNAP One Sleep Therapy System?

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 The iNAP One Sleep Therapy System?

The FDA product code for The iNAP One Sleep Therapy System is OZR.

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。

K152660HYPNOSPAD

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