FDA 510(k)

PowerDot PD-01M

K 號：K172876 · 2017-12-04

決定日期2017-12-04

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

PowerDot PD-01M 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 2017-12-04 under 510(k) number K172876. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerDot PD-01M?

PowerDot PD-01M is a medical device that received FDA 510(k) clearance on 2017-12-04. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K172876.

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

PowerDot PD-01M received FDA 510(k) clearance on 2017-12-04, under 510(k) number K172876.

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

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-01M?

The FDA product code for PowerDot PD-01M is NGX.

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：NGX）

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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