FDA 510(k)

Erchonia XLR8

K 號：K211186 · 2021-10-22

決定日期2021-10-22

產品代碼NHN

諮詢委員會PM

決定相當於

器材摘要

Erchonia XLR8 is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K211186. 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 XLR8?

Erchonia XLR8 is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Erchonia Corporation. The 510(k) number is K211186.

When did Erchonia XLR8 receive FDA 510(k) clearance?

Erchonia XLR8 received FDA 510(k) clearance on 2021-10-22, under 510(k) number K211186.

Who is the listed applicant for Erchonia XLR8?

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 XLR8?

The FDA product code for Erchonia XLR8 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

官方來源

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