FDA 510(k)

太陽能精簡型（G4-1）

K 號：K240007 · 2024-05-06

決定日期2024-05-06

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

Solar Compact (G4-1) is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-05-06 under 510(k) number K240007. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solar Compact (G4-1)?

Solar Compact (G4-1) is a medical device that received FDA 510(k) clearance on 2024-05-06. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K240007.

When did Solar Compact (G4-1) receive FDA 510(k) clearance?

Solar Compact (G4-1) received FDA 510(k) clearance on 2024-05-06, under 510(k) number K240007.

Who is the listed applicant for Solar Compact (G4-1)?

The FDA 510(k) record lists Laborie Medical Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solar Compact (G4-1)?

The FDA product code for Solar Compact (G4-1) is FFX.

其他以 Laborie Medical Technologies, Corp. 為申請人之記錄

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相關器械（代碼：FFX）

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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