Cleared Traditional

DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE

K041790 · Datex-Ohmeda · Cardiovascular
Jul 2004
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K041790 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE, 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 July 23, 2004, 21 days after receiving the submission on July 2, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K041790 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2004
Decision Date July 23, 2004
Days to Decision 21 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