FDA 510(k)

治療EC，治療XT

K 號：K232813 · 2024-12-19

申請人Dmc Importacao E Exportacao DE Equipamentos Ltda

決定日期2024-12-19

產品代碼NHN

諮詢委員會PM

決定相當於

器材摘要

Therapy EC, Therapy XT is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K232813. 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 Therapy EC, Therapy XT?

Therapy EC, Therapy XT is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. The 510(k) number is K232813.

When did Therapy EC, Therapy XT receive FDA 510(k) clearance?

Therapy EC, Therapy XT received FDA 510(k) clearance on 2024-12-19, under 510(k) number K232813.

Who is the listed applicant for Therapy EC, Therapy XT?

The FDA 510(k) record lists Dmc Importacao E Exportacao DE Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therapy EC, Therapy XT?

The FDA product code for Therapy EC, Therapy XT is NHN.

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..K231409Erchonia FX-405Erchonia Corporation K212189維布羅盧克斯Multi Radiance Medical

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NHN）

官方來源