Cleared Special

ST/AR ST AND ARRHYTHMIA SOFTWARE

K001348 · Agilent Technologies, Inc. · Cardiovascular
May 2000
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K001348 is an FDA 510(k) clearance for the ST/AR ST AND ARRHYTHMIA SOFTWARE, 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 17, 2000, 19 days after receiving the submission on April 28, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K001348 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2000
Decision Date May 17, 2000
Days to Decision 19 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

Similar Devices — MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 418
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 2025
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025