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FDA 510(k)

巨脉冲III短波電熱療法器

K 號:K153456 · 2016-06-14

決定日期2016-06-14
產品代碼IMJ
諮詢委員會PM
決定相當於

器材摘要

Megapulse III Shortwave Diathermy is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Care Plus. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K153456. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Megapulse III Shortwave Diathermy?

Megapulse III Shortwave Diathermy is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Accelerated Care Plus. The 510(k) number is K153456.

When did Megapulse III Shortwave Diathermy receive FDA 510(k) clearance?

Megapulse III Shortwave Diathermy received FDA 510(k) clearance on 2016-06-14, under 510(k) number K153456.

Who is the listed applicant for Megapulse III Shortwave Diathermy?

The FDA 510(k) record lists Accelerated Care Plus as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Megapulse III Shortwave Diathermy?

The FDA product code for Megapulse III Shortwave Diathermy is IMJ.

相關臨床試驗

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相關器械(代碼:IMJ)

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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