Cleared Traditional

ECARD AND CCARD

K081471 · iRhythm Technologies, Inc. · Cardiovascular
Jun 2008
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K081471 is an FDA 510(k) clearance for the ECARD AND CCARD, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 24, 2008, 28 days after receiving the submission on May 27, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K081471 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2008
Decision Date June 24, 2008
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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