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FDA 510(k) K232686 CorVista System Full Submission by CorVista Health
FDA 510(k) K232686 CorVista System Full Submission by CorVista Health
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Original Request: Full 510(k) Request (Number - K232686) of the CorVista Health, Inc. (“CorVista Health”), for the CorVista® System under the Common name of"Cardiovascular machine learning-based notification software", Classification: Class II, Regulation number: 21 CFR 870.2380, Classification Panel: Cardiovascular Product Code: QXX Subsequent Product Code: DQK
Tags: MedTech, 510(k), 2024
Tags: MedTech, 510(k), 2024
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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