FDA 510(k)

iNAP One 睡眠治療系統

K 號：K220907 · 2023-06-16

決定日期2023-06-16

產品代碼OZR

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Somnics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K152660催眠噴射器

相關器械（代碼：OZR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K193460iNAP One 睡眠治療系統Somnice, Inc.

官方來源

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