Cleared Special

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION

K073550 · Nihon Kohden America, Inc. · Cardiovascular
Mar 2008
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K073550 is an FDA 510(k) clearance for the PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on March 28, 2008, 101 days after receiving the submission on December 18, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K073550 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2007
Decision Date March 28, 2008
Days to Decision 101 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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