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FDA 510(k)

治療美國

K 號:K252273 · 2025-12-12

決定日期2025-12-12
產品代碼NHN
諮詢委員會PM
決定相當於

器材摘要

Therapy US is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252273. 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 US?

Therapy US is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. The 510(k) number is K252273.

When did Therapy US receive FDA 510(k) clearance?

Therapy US received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252273.

Who is the listed applicant for Therapy US?

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

What is the FDA product code for Therapy US?

The FDA product code for Therapy US is NHN.

相關臨床試驗

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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。

官方來源

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