Cleared Traditional

DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM

K950480 · Nikomed U.S.A., Inc. · Cardiovascular
Nov 1995
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K950480 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM, 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 November 6, 1995, 276 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 K950480 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1995
Decision Date November 06, 1995
Days to Decision 276 days
Submission Type Traditional
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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