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FDA 510(k)

XP1100 RF

K 號:K152731 · 2016-07-20

決定日期2016-07-20
產品代碼GEI
諮詢委員會SU
決定Substantially Equivalent

器材摘要

XP1100 RF is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152731. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XP1100 RF?

XP1100 RF is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is BTL Industries, Inc.. The 510(k) number is K152731.

When did XP1100 RF receive FDA 510(k) clearance?

XP1100 RF received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152731.

Who is the listed applicant for XP1100 RF?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XP1100 RF?

The FDA product code for XP1100 RF is GEI.

其他以 BTL Industries, Inc. 為申請人之記錄

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相關器械(代碼:GEI)

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