FDA 510(k)

Erchonia 琥珀

K 號：K192544 · 2020-01-13

決定日期2020-01-13

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 Emerald is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2020-01-13 under 510(k) number K192544. 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 Emerald?

Erchonia Emerald is a medical device that received FDA 510(k) clearance on 2020-01-13. The listed applicant is Erchonia Corporation. The 510(k) number is K192544.

When did Erchonia Emerald receive FDA 510(k) clearance?

Erchonia Emerald received FDA 510(k) clearance on 2020-01-13, under 510(k) number K192544.

Who is the listed applicant for Erchonia Emerald?

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 Emerald?

The FDA product code for Erchonia Emerald 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。

K251903Erchonia DPN雷射（型號# EVRL）K252574Erchonia CLX（型號 # CFL）K251843Erchonia EVRL K243811Erchonia Zerona® VZ8 K231409Erchonia FX-405 K231474Erchonia 紫羅蘭 ZERONA® Z6 非處方藥

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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。

K260688雕塑LED帶 (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro)Shenzhen Kaiyan Medical Equipment Co., Ltd.K243854Contour Light (CL-100)Contour Research, LLC K252574Erchonia CLX（型號 # CFL）Erchonia Corporation K252786LED光療床（Pro 450/ GY-680A）Shenzhen Suyzeko Limited.K243811Erchonia Zerona® VZ8Erchonia Corporation

官方來源

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