Cleared Traditional

EKGCARD SYSTEM

K030535 · Qrs Diagnostic, LLC · Cardiovascular
Jun 2003
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K030535 is an FDA 510(k) clearance for the EKGCARD SYSTEM, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on June 11, 2003, 111 days after receiving the submission on February 20, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K030535 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2003
Decision Date June 11, 2003
Days to Decision 111 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