Cleared Special

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

K082785 · Nihon Kohden America, Inc. · Cardiovascular
Nov 2008
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K082785 is an FDA 510(k) clearance for the NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES, 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 November 26, 2008, 64 days after receiving the submission on September 23, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K082785 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2008
Decision Date November 26, 2008
Days to Decision 64 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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