CorVista® 系統
K 號：K232686 · 2023-09-08
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器材摘要
CorVista® System is the device name listed in this FDA 510(k) record. The listed applicant is Corvista Health, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K232686. The device is classified under product code QXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CorVista® System?
CorVista® System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Corvista Health, Inc.. The 510(k) number is K232686.
When did CorVista® System receive FDA 510(k) clearance?
CorVista® System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232686.
Who is the listed applicant for CorVista® System?
The FDA 510(k) record lists Corvista Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CorVista® System?
The FDA product code for CorVista® System is QXX.
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官方來源
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