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FDA 510(k)

JLK-PWI

K 號：K242709 · 2024-11-04

申請人JLK, Inc.
決定日期2024-11-04
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

JLK-PWI is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K242709. 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 JLK-PWI?

JLK-PWI is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is JLK, Inc.. The 510(k) number is K242709.

When did JLK-PWI receive FDA 510(k) clearance?

JLK-PWI received FDA 510(k) clearance on 2024-11-04, under 510(k) number K242709.

Who is the listed applicant for JLK-PWI?

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

What is the FDA product code for JLK-PWI?

The FDA product code for JLK-PWI is LLZ.

其他以 JLK, Inc. 為申請人之記錄

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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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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