Cleared Traditional

Triangle System

K183319 · AliveCor, Inc. · Cardiovascular
May 2019
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K183319 is an FDA 510(k) clearance for the Triangle System, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 10, 2019, 161 days after receiving the submission on November 30, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K183319 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2018
Decision Date May 10, 2019
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

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