MLD · Class II · 21 CFR 870.1025

FDA Product Code MLD: Monitor, St Segment With Alarm

Leading manufacturers include Siemens Medical Solutions USA, Inc. 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 Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Feb 26, 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
K974492
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
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