FDA 510(k)

CS-Pro醫療設備規範文本

K 號：K250779 · 2025-07-02

決定日期2025-07-02

產品代碼PZL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

CS-Pro MED is the device name listed in this FDA 510(k) record. The listed applicant is Curative Sound Therapeutics. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250779. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CS-Pro MED?

CS-Pro MED is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Curative Sound Therapeutics. The 510(k) number is K250779.

When did CS-Pro MED receive FDA 510(k) clearance?

CS-Pro MED received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250779.

Who is the listed applicant for CS-Pro MED?

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

What is the FDA product code for CS-Pro MED?

The FDA product code for CS-Pro MED is PZL.

相關器械（代碼：PZL）

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官方來源

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