FDA 510(k)

SLENDERTONE CoreFit Abs 8，型號 734

K 號：K180688 · 2018-10-25

決定日期2018-10-25

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

SLENDERTONE CoreFit Abs 8, Type 734 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K180688. 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 SLENDERTONE CoreFit Abs 8, Type 734?

SLENDERTONE CoreFit Abs 8, Type 734 is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K180688.

When did SLENDERTONE CoreFit Abs 8, Type 734 receive FDA 510(k) clearance?

SLENDERTONE CoreFit Abs 8, Type 734 received FDA 510(k) clearance on 2018-10-25, under 510(k) number K180688.

Who is the listed applicant for SLENDERTONE CoreFit Abs 8, Type 734?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLENDERTONE CoreFit Abs 8, Type 734?

The FDA product code for SLENDERTONE CoreFit Abs 8, Type 734 is NGX.

其他以 Bio-Medical Research, 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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