Cleared Traditional

DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM

K950479 · Nikomed U.S.A., Inc. · Cardiovascular
Sep 1995
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K950479 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Nikomed U.S.A., Inc. (Doylestown, US). The FDA issued a Cleared decision on September 13, 1995, 222 days after receiving the submission on February 3, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K950479 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1995
Decision Date September 13, 1995
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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