維奧拉
K 號：K190264 · 2019-08-15
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器材摘要
Viola is the device name listed in this FDA 510(k) record. The listed applicant is Meditime Co., Ltd.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190264. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Viola?
Viola is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Meditime Co., Ltd.. The 510(k) number is K190264.
When did Viola receive FDA 510(k) clearance?
Viola received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190264.
Who is the listed applicant for Viola?
The FDA 510(k) record lists Meditime Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Viola?
The FDA product code for Viola is NEW.
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相關 PubMed 文獻
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相關器械（代碼：NEW）
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官方來源
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