Cleared Special

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M

K072217 · Nihon Kohden America, Inc. · Cardiovascular
Aug 2007
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K072217 is an FDA 510(k) clearance for the ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M, 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 30, 2007, 21 days after receiving the submission on August 9, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K072217 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2007
Decision Date August 30, 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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