FDA 510(k)

睡眠呼吸中止症通知功能（SANF）

K 號：K240929 · 2024-09-13

決定日期2024-09-13

產品代碼QZW

諮詢委員會AN

決定相當於

器材摘要

Sleep Apnea Notification Feature (SANF) is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240929. The device is classified under product code QZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sleep Apnea Notification Feature (SANF)?

Sleep Apnea Notification Feature (SANF) is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Apple, Inc.. The 510(k) number is K240929.

When did Sleep Apnea Notification Feature (SANF) receive FDA 510(k) clearance?

Sleep Apnea Notification Feature (SANF) received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240929.

Who is the listed applicant for Sleep Apnea Notification Feature (SANF)?

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

What is the FDA product code for Sleep Apnea Notification Feature (SANF)?

The FDA product code for Sleep Apnea Notification Feature (SANF) is QZW.

其他以 Apple, 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。

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相關器械（代碼：QZW）

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。

K261011睡眠呼吸中止症特徵（v2.0）Samsung Electronics Co., Ltd.

官方來源

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