Corvair Monza
K-Number: K252589 · 2026-01-09
ApplicantAliveCor, Inc.
Decision Date2026-01-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Corvair Monza is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2026-01-09 under approval number K252589. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Corvair Monza?
Corvair Monza is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by AliveCor, Inc.. The 510(k) number is K252589.
When was Corvair Monza approved by the FDA?
Corvair Monza received FDA 510(k) clearance on 2026-01-09, under approval number K252589.
What company makes Corvair Monza?
Corvair Monza is manufactured by AliveCor, Inc..
What is the FDA product code for Corvair Monza?
The FDA product code for Corvair Monza is MHX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.