FDA 510(k)

安心系統

K 號：K233497 · 2024-10-03

決定日期2024-10-03

產品代碼PLC

諮詢委員會DE

決定相當於

器材摘要

Rest Assure System is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K233497. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rest Assure System?

Rest Assure System is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Somnomed, Inc.. The 510(k) number is K233497.

When did Rest Assure System receive FDA 510(k) clearance?

Rest Assure System received FDA 510(k) clearance on 2024-10-03, under 510(k) number K233497.

Who is the listed applicant for Rest Assure System?

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

What is the FDA product code for Rest Assure System?

The FDA product code for Rest Assure System is PLC.

其他以 Somnomed, Inc. 為申請人之記錄

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相關器械（代碼：PLC）

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