FDA 510(k)

SLENDERTONE® Connect Abs, 型號 570

K 號：K161974 · 2016-11-01

決定日期2016-11-01

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

SLENDERTONE® Connect Abs, Type 570 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 2016-11-01 under 510(k) number K161974. 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® Connect Abs, Type 570?

SLENDERTONE® Connect Abs, Type 570 is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K161974.

When did SLENDERTONE® Connect Abs, Type 570 receive FDA 510(k) clearance?

SLENDERTONE® Connect Abs, Type 570 received FDA 510(k) clearance on 2016-11-01, under 510(k) number K161974.

Who is the listed applicant for SLENDERTONE® Connect Abs, Type 570?

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® Connect Abs, Type 570?

The FDA product code for SLENDERTONE® Connect Abs, Type 570 is NGX.

其他以 Bio-Medical Research, Ltd. 為申請人之記錄

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