Cleared Special

NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201

K102376 · Nihon Kohden Corp. · Cardiovascular
Dec 2010
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K102376 is an FDA 510(k) clearance for the NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on December 7, 2010, 109 days after receiving the submission on August 20, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K102376 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2010
Decision Date December 07, 2010
Days to Decision 109 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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