FDA 510(k)

SANSA HSAT

K 號：K252497 · 2025-12-10

決定日期2025-12-10

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

SANSA HSAT is the device name listed in this FDA 510(k) record. The listed applicant is Huxley Medical. It received FDA 510(k) clearance on 2025-12-10 under 510(k) number K252497. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SANSA HSAT?

SANSA HSAT is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Huxley Medical. The 510(k) number is K252497.

When did SANSA HSAT receive FDA 510(k) clearance?

SANSA HSAT received FDA 510(k) clearance on 2025-12-10, under 510(k) number K252497.

Who is the listed applicant for SANSA HSAT?

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

What is the FDA product code for SANSA HSAT?

The FDA product code for SANSA HSAT is MNR.

其他以 Huxley Medical 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。

K250882SANSA HSAT K244027SANSA HSAT K240285胡克萊 SANSA 家用睡眠呼吸中止測試 (1000-00)

相關器械（代碼：MNR）

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。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K250882SANSA HSATHuxley Medical

官方來源

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