FDA 510(k)低頻多功能物理治療儀
K 號：K200177 · 2021-03-25
決定日期2021-03-25
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 Multi-function physiotherapy instrument 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 2021-03-25 under 510(k) number K200177. 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 Multi-function physiotherapy instrument?
Low-frequency Multi-function physiotherapy instrument is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K200177.
When did Low-frequency Multi-function physiotherapy instrument receive FDA 510(k) clearance?
Low-frequency Multi-function physiotherapy instrument received FDA 510(k) clearance on 2021-03-25, under 510(k) number K200177.
Who is the listed applicant for Low-frequency Multi-function physiotherapy instrument?
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 Multi-function physiotherapy instrument?
The FDA product code for Low-frequency Multi-function physiotherapy instrument is NUH.
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