Cleared Traditional

Corvair

K231010 · AliveCor, Inc. · Cardiovascular
Jun 2024
Decision
427d
Days
Class 2
Risk

About This 510(k) Submission

K231010 is an FDA 510(k) clearance for the Corvair, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2024, 427 days after receiving the submission on April 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K231010 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2023
Decision Date June 07, 2024
Days to Decision 427 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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