Impala
K-Number: K232035 · 2024-06-07
ApplicantAliveCor, Inc.
Decision Date2024-06-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Impala is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2024-06-07 under approval number K232035. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Impala?
Impala is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by AliveCor, Inc.. The 510(k) number is K232035.
When was Impala approved by the FDA?
Impala received FDA 510(k) clearance on 2024-06-07, under approval number K232035.
What company makes Impala?
Impala is manufactured by AliveCor, Inc..
What is the FDA product code for Impala?
The FDA product code for Impala is DPS.
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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.