Cleared Special

QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V

K072060 · Nihon Kohden America, Inc. · Cardiovascular
Aug 2007
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K072060 is an FDA 510(k) clearance for the QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V, 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 August 17, 2007, 21 days after receiving the submission on July 27, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K072060 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2007
Decision Date August 17, 2007
Days to Decision 21 days
Submission Type Special
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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