Cleared Traditional

DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE

K043276 · Datex-Ohmeda · Cardiovascular
Dec 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K043276 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on December 23, 2004, 27 days after receiving the submission on November 26, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K043276 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2004
Decision Date December 23, 2004
Days to Decision 27 days
Submission Type Traditional
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