FDA 510(k)

Erchonia Zerona® VZ8

K 號：K243811 · 2025-01-10

決定日期2025-01-10

產品代碼OLI

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

Erchonia Zerona® VZ8 is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K243811. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Erchonia Zerona® VZ8?

Erchonia Zerona® VZ8 is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Erchonia Corporation. The 510(k) number is K243811.

When did Erchonia Zerona® VZ8 receive FDA 510(k) clearance?

Erchonia Zerona® VZ8 received FDA 510(k) clearance on 2025-01-10, under 510(k) number K243811.

Who is the listed applicant for Erchonia Zerona® VZ8?

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

What is the FDA product code for Erchonia Zerona® VZ8?

The FDA product code for Erchonia Zerona® VZ8 is OLI.

其他以 Erchonia Corporation 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：OLI）

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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