MLO · Class II · 21 CFR 870.2800

FDA Product Code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Leading manufacturers include Inovise Medical, Inc., Agilent Technologies and Galix Biomedical Instrumentation, Inc..

33
Total
33
Cleared
192d
Avg days
1999
Since
33 devices
25–33 of 33
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 581d
Cleared Feb 08, 2001
2010 PLUS HOLTER FOR WINDOWS
K003940
Agilent Technologies
Cardiovascular · 49d
Cleared Jan 05, 2001
2010 PLUS HOLTER FOR WINDOWS
K003763
Agilent Technologies
Cardiovascular · 30d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788
Novacor Div.
Cardiovascular · 269d
Cleared Jul 28, 1999
MODIFICATION TO ZYMED HOLTER 2000
K992197
Zymed Medical Instrumentation
Cardiovascular · 28d
Cleared Apr 13, 1999
HOLTER 2000
K990170
Zymed Medical Instrumentation
Cardiovascular · 84d