Cleared Traditional

CARDIOFAX CE, MODEL ECG-1500 A

K052511 · Nihon Kohden America, Inc. · Cardiovascular
May 2006
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K052511 is an FDA 510(k) clearance for the CARDIOFAX CE, MODEL ECG-1500 A, 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 May 24, 2006, 252 days after receiving the submission on September 14, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K052511 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2005
Decision Date May 24, 2006
Days to Decision 252 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

More from Nihon Kohden America, Inc.

View all
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · GWQ · Mar 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
K120485 · OMA · Mar 2012
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573 · OMA · Jul 2010
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456 · CCK · Mar 2009
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
K083271 · MHX · Dec 2008