FDA 510(k)

CorVista System with PH Add-On

K-Number: K233666 · 2024-04-05

Decision Date2024-04-05

Product CodeSAT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CorVista System with PH Add-On is the device name listed in this FDA 510(k) record. The listed applicant is Analytics For Life, Inc.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233666. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorVista System with PH Add-On?

CorVista System with PH Add-On is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Analytics For Life, Inc.. The 510(k) number is K233666.

When did CorVista System with PH Add-On receive FDA 510(k) clearance?

CorVista System with PH Add-On received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233666.

Who is the listed applicant for CorVista System with PH Add-On?

The FDA 510(k) record lists Analytics For Life, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorVista System with PH Add-On?

The FDA product code for CorVista System with PH Add-On is SAT.

Other records listing Analytics For Life, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-On

Related Devices (Code: SAT)

K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.