Cleared Traditional

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570

K990111 · Maersk Medical A/S · Cardiovascular
Dec 1999
Decision
327d
Days
Class 2
Risk

About This 510(k) Submission

K990111 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Maersk Medical A/S (Fort Worth, US). The FDA issued a Cleared decision on December 6, 1999, 327 days after receiving the submission on January 13, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K990111 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1999
Decision Date December 06, 1999
Days to Decision 327 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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