Cleared Traditional

AccurECG Analysis System

K223013 · Accurkardia, Inc. · Cardiovascular
Jun 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K223013 is an FDA 510(k) clearance for the AccurECG Analysis System, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Accurkardia, Inc. (New York, US). The FDA issued a Cleared decision on June 23, 2023, 267 days after receiving the submission on September 29, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K223013 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date June 23, 2023
Days to Decision 267 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