Cleared Traditional

DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE

K022740 · Datex-Ohmeda · Cardiovascular
Nov 2002
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K022740 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE, a Monitor, St Segment With Alarm (Class II — Special Controls, product code MLD), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on November 14, 2002, 87 days after receiving the submission on August 19, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K022740 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date November 14, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MLD — Monitor, St Segment With Alarm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — MLD Monitor, St Segment With Alarm

All 13
VITAL SIGNS MONITOR
K101602 · Criticare Systems, Inc. · Sep 2010
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461 · Philips Medical Systems · Mar 2008
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · Datex-Ohmeda · Sep 2001
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · Siemens Medical Solutions USA, Inc. · Dec 2000
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · Datex-Ohmeda, Inc. · Nov 1999
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · Medical Data Electronics · Nov 1998