Cleared Special

COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120

K001664 · Agilent Technologies, Inc. · Cardiovascular
Jun 2000
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K001664 is an FDA 510(k) clearance for the COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120, 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 June 30, 2000, 30 days after receiving the submission on May 31, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K001664 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2000
Decision Date June 30, 2000
Days to Decision 30 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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