Cleared Traditional

CARDIOFAX CE, MODEL PEA-1110K

K042827 · Nihon Kohden America, Inc. · Cardiovascular
Jan 2005
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K042827 is an FDA 510(k) clearance for the CARDIOFAX CE, MODEL PEA-1110K, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on January 6, 2005, 86 days after receiving the submission on October 12, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K042827 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2004
Decision Date January 06, 2005
Days to Decision 86 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

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