VIVACE 电外科系统
K号: K150409 · 2016-01-15
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决定日期2016-01-15
产品代码OUH
咨询委员会SU
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器械摘要
VIVACE Electrosurgical System is the device name listed in this FDA 510(k) record. The listed applicant is Sung Hwan E&B Co.,Ltd. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K150409. The device is classified under product code OUH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VIVACE Electrosurgical System?
VIVACE Electrosurgical System is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Sung Hwan E&B Co.,Ltd. The 510(k) number is K150409.
When did VIVACE Electrosurgical System receive FDA 510(k) clearance?
VIVACE Electrosurgical System received FDA 510(k) clearance on 2016-01-15, under 510(k) number K150409.
Who is the listed applicant for VIVACE Electrosurgical System?
The FDA 510(k) record lists Sung Hwan E&B Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VIVACE Electrosurgical System?
The FDA product code for VIVACE Electrosurgical System is OUH.
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