FDA 510(k)

PowerDot PD-01MT

K 號：K181759 · 2018-11-09

決定日期2018-11-09

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

PowerDot PD-01MT is the device name listed in this FDA 510(k) record. The listed applicant is Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181759. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerDot PD-01MT?

PowerDot PD-01MT is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K181759.

When did PowerDot PD-01MT receive FDA 510(k) clearance?

PowerDot PD-01MT received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181759.

Who is the listed applicant for PowerDot PD-01MT?

The FDA 510(k) record lists Smartmissimo Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDot PD-01MT?

The FDA product code for PowerDot PD-01MT is IPF.

其他以 Smartmissimo Technologies Pte, Ltd. 為申請人之記錄

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。

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相關器械（代碼：IPF）

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。

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官方來源

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