FDA 510(k)

Hypnos (369054-200)

K 號：K250851 · 2025-12-14

決定日期2025-12-14

產品代碼OLZ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Hypnos (369054-200) is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2025-12-14 under 510(k) number K250851. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hypnos (369054-200)?

Hypnos (369054-200) is a medical device that received FDA 510(k) clearance on 2025-12-14. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K250851.

When did Hypnos (369054-200) receive FDA 510(k) clearance?

Hypnos (369054-200) received FDA 510(k) clearance on 2025-12-14, under 510(k) number K250851.

Who is the listed applicant for Hypnos (369054-200)?

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

What is the FDA product code for Hypnos (369054-200)?

The FDA product code for Hypnos (369054-200) is OLZ.

其他以 Cadwell Industries, Inc. 為申請人之記錄

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相關器械（代碼：OLZ）

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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官方來源

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