Cleared Traditional

RHYTHMSTAR SYSTEM

K141813 · RhythMedix, LLC · Cardiovascular

Aug 2014

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K141813 is an FDA 510(k) clearance for the RHYTHMSTAR SYSTEM, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by RhythMedix, LLC (Minneapolis, US). The FDA issued a Cleared decision on August 5, 2014, 29 days after receiving the submission on July 7, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K141813 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2014
Decision Date	August 05, 2014
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF