FDA 510(k)

Klär Lite (RCW-KL1000)

K 號：K253871 · 2026-03-04

決定日期2026-03-04

產品代碼FTC

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

Klär Lite (RCW-KL1000) is the device name listed in this FDA 510(k) record. The listed applicant is Radcliffe Watts, LLC. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253871. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Klär Lite (RCW-KL1000)?

Klär Lite (RCW-KL1000) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Radcliffe Watts, LLC. The 510(k) number is K253871.

When did Klär Lite (RCW-KL1000) receive FDA 510(k) clearance?

Klär Lite (RCW-KL1000) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253871.

Who is the listed applicant for Klär Lite (RCW-KL1000)?

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

What is the FDA product code for Klär Lite (RCW-KL1000)?

The FDA product code for Klär Lite (RCW-KL1000) is FTC.

相關器械（代碼：FTC）

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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