DW-1C
K号: K160761 · 2016-11-22
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决定日期2016-11-22
产品代码NEW
咨询委员会SU
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决定实质等同
器械摘要
DW-1C is the device name listed in this FDA 510(k) record. The listed applicant is Dongwon Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160761. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DW-1C?
DW-1C is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Dongwon Medical Co., Ltd.. The 510(k) number is K160761.
When did DW-1C receive FDA 510(k) clearance?
DW-1C received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160761.
Who is the listed applicant for DW-1C?
The FDA 510(k) record lists Dongwon Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DW-1C?
The FDA product code for DW-1C is NEW.
相关器械（代码：NEW）
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官方来源
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