Cleared Traditional

Impala

K232035 · AliveCor, Inc. · Cardiovascular
Jun 2024
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K232035 is an FDA 510(k) clearance for the Impala, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2024, 336 days after receiving the submission on July 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K232035 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date June 07, 2024
Days to Decision 336 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340