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FDA 510(k)

電子止汗器,敏感型電子止汗器,精英型電子止汗器

K 號:K170835 · 2018-06-15

決定日期2018-06-15
產品代碼EGJ
諮詢委員會PM
決定相當於

器材摘要

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Hightech Development. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K170835. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Hightech Development. The 510(k) number is K170835.

When did Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE receive FDA 510(k) clearance?

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE received FDA 510(k) clearance on 2018-06-15, under 510(k) number K170835.

Who is the listed applicant for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

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

What is the FDA product code for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

The FDA product code for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is EGJ.

相關臨床試驗

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相關器械(代碼:EGJ)

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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