FDA 510(k)低頻治療儀 / 型號：KTR-201，KTR-202，KTR-203
K 號：K170205 · 2017-05-11
決定日期2017-05-11
產品代碼NUH
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
決定相當於
器材摘要
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170205. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K170205.
When did Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 receive FDA 510(k) clearance?
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170205.
Who is the listed applicant for Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?
The FDA 510(k) record lists Shenzhen Kentro Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?
The FDA product code for Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is NUH.
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