FDA 510(k)

RW-1

K 號：K232456 · 2025-08-11

決定日期2025-08-11

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

RW-1 is the device name listed in this FDA 510(k) record. The listed applicant is Mediott, Inc.. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K232456. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RW-1?

RW-1 is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Mediott, Inc.. The 510(k) number is K232456.

When did RW-1 receive FDA 510(k) clearance?

RW-1 received FDA 510(k) clearance on 2025-08-11, under 510(k) number K232456.

Who is the listed applicant for RW-1?

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

What is the FDA product code for RW-1?

The FDA product code for RW-1 is LLZ.

其他以 Mediott, Inc. 為申請人之記錄

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K253029RW-1

相關器械（代碼：LLZ）

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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