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FDA 510(k)

ProMedTek 模型 C1400 短波電熱治療器

K 號:K162240 · 2016-11-17

決定日期2016-11-17
產品代碼IMJ
諮詢委員會PM
決定相當於

器材摘要

ProMedTek Model C1400 Shortwave Diathermy Device is the device name listed in this FDA 510(k) record. The listed applicant is Promedtek, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162240. 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 ProMedTek Model C1400 Shortwave Diathermy Device?

ProMedTek Model C1400 Shortwave Diathermy Device is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Promedtek, Inc.. The 510(k) number is K162240.

When did ProMedTek Model C1400 Shortwave Diathermy Device receive FDA 510(k) clearance?

ProMedTek Model C1400 Shortwave Diathermy Device received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162240.

Who is the listed applicant for ProMedTek Model C1400 Shortwave Diathermy Device?

The FDA 510(k) record lists Promedtek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device?

The FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device 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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