FDA 510(k)

Erchonia FX-635

K 號：K180197 · 2018-05-21

決定日期2018-05-21

產品代碼NHN

諮詢委員會PM

決定相當於

器材摘要

Erchonia FX-635 is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180197. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Erchonia FX-635?

Erchonia FX-635 is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Erchonia Corporation. The 510(k) number is K180197.

When did Erchonia FX-635 receive FDA 510(k) clearance?

Erchonia FX-635 received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180197.

Who is the listed applicant for Erchonia FX-635?

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 FX-635?

The FDA product code for Erchonia FX-635 is NHN.

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：NHN）

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。

K254024MR5 活動專業版Multi Radiance Medical, Inc.K251903Erchonia DPN雷射（型號# EVRL）Erchonia Corporation K252273治療美國Dmc Importação E Exportação DE Equipamentos Ltda K241057強化手持式疼痛緩解雷射儀器（GD-P-E）Wuhan Guangdun Technology Co.,Ltd..K232813治療EC，治療XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation

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