Cleared Special

BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY

K083271 · Nihon Kohden America, Inc. · Cardiovascular
Dec 2008
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K083271 is an FDA 510(k) clearance for the BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY, 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 December 24, 2008, 48 days after receiving the submission on November 6, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K083271 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2008
Decision Date December 24, 2008
Days to Decision 48 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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