FDA 510(k)

設備名稱醫療設備規範文本產品名稱：Sonu 公司名稱：[公司名稱] FDA許可證號：[FDA許可證號] 510(k)許可證號：[510(k)許可證號] PMA許可證號：[PMA許可證號] NCT編號：[NCT編號] PMID編號：[PMID編號] 識別碼：[識別碼] 網址：[網址]

K 號：K242214 · 2025-04-24

決定日期2025-04-24

產品代碼QZC

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

Sonu is the device name listed in this FDA 510(k) record. The listed applicant is Sound Health Systems, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K242214. The device is classified under product code QZC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sonu?

Sonu is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Sound Health Systems, Inc.. The 510(k) number is K242214.

When did Sonu receive FDA 510(k) clearance?

Sonu received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242214.

Who is the listed applicant for Sonu?

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

What is the FDA product code for Sonu?

The FDA product code for Sonu is QZC.

官方來源

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