FDA 510(k)

Zerona Z6 非處方藥

K 號：K162578 · 2016-12-16

決定日期2016-12-16

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

Zerona Z6 OTC is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K162578. 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 Zerona Z6 OTC?

Zerona Z6 OTC is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Erchonia Corporation. The 510(k) number is K162578.

When did Zerona Z6 OTC receive FDA 510(k) clearance?

Zerona Z6 OTC received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162578.

Who is the listed applicant for Zerona Z6 OTC?

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 Zerona Z6 OTC?

The FDA product code for Zerona Z6 OTC 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

查看所有 17 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。