VIO系统（V-1000）
K号: K232789 · 2023-12-22
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决定日期2023-12-22
产品代码QZN
咨询委员会SU
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器械摘要
VIO System (V-1000) is the device name listed in this FDA 510(k) record. The listed applicant is Enspectra Health, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232789. The device is classified under product code QZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VIO System (V-1000)?
VIO System (V-1000) is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Enspectra Health, Inc.. The 510(k) number is K232789.
When did VIO System (V-1000) receive FDA 510(k) clearance?
VIO System (V-1000) received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232789.
Who is the listed applicant for VIO System (V-1000)?
The FDA 510(k) record lists Enspectra Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VIO System (V-1000)?
The FDA product code for VIO System (V-1000) is QZN.
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