Cleared Special

AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154

K011093 · Agilent Technologies, Inc. · Cardiovascular
May 2001
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K011093 is an FDA 510(k) clearance for the AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on May 1, 2001, 21 days after receiving the submission on April 10, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K011093 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2001
Decision Date May 01, 2001
Days to Decision 21 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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