MLD · Class II · 21 CFR 870.1025

FDA Product Code MLD: Monitor, St Segment With Alarm

Leading manufacturers include Siemens Medical Solutions USA, Inc., Datex-Ohmeda and Hewlett-Packard Co..

14
Total
14
Cleared
207d
Avg days
1993
Since

FDA 510(k) Cleared Monitor, St Segment With Alarm Devices (Product Code MLD)

14 devices
1–14 of 14
Cleared Mar 13, 2008
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461
Philips Medical Systems
Cardiovascular · 22d
Cleared Nov 14, 2002
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
K022740
Datex-Ohmeda
Cardiovascular · 87d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837
Datex-Ohmeda
Cardiovascular · 22d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Nov 01, 1999
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323
Datex-Ohmeda, Inc.
Cardiovascular · 112d
Cleared Feb 26, 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
K974492
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Feb 06, 1997
AS/3 ESTPR MODULE
K953175
Datex Division Instrumentarium Corp.
Cardiovascular · 580d
Cleared Oct 02, 1996
EAGLE 3000/3100 PATIENT MONITOR
K960272
Marquette Electronics, Inc.
Cardiovascular · 258d
Cleared Jun 14, 1996
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
K960934
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Jul 20, 1993
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
K920429
Hewlett-Packard Co.
Cardiovascular · 533d

About Product Code MLD - Regulatory Context