Cleared Traditional

Kardia Band System

K171816 · AliveCor, Inc. · Cardiovascular
Nov 2017
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K171816 is an FDA 510(k) clearance for the Kardia Band 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 November 16, 2017, 150 days after receiving the submission on June 19, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K171816 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2017
Decision Date November 16, 2017
Days to Decision 150 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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