Cleared Special

NIKOMED TRACE 1 ECG ELECTRODES

K022909 · Nikomed U.S.A., Inc. · Cardiovascular
Jan 2003
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K022909 is an FDA 510(k) clearance for the NIKOMED TRACE 1 ECG ELECTRODES, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Nikomed U.S.A., Inc. (Stillwater, US). The FDA issued a Cleared decision on January 9, 2003, 128 days after receiving the submission on September 3, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K022909 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2002
Decision Date January 09, 2003
Days to Decision 128 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

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