Cleared Special

ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0

K003621 · Agilent Technologies, Inc. · Cardiovascular
Dec 2000
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K003621 is an FDA 510(k) clearance for the ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0, 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 December 20, 2000, 26 days after receiving the submission on November 24, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K003621 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2000
Decision Date December 20, 2000
Days to Decision 26 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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