Aspect Medical Systems, Inc. - FDA 510(k) Cleared Devices
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aspect Medical Systems, Inc. Neurology ✕
24 devices
Cleared
Oct 23, 2009
BIS QUATRO SENSOR
Neurology
14d
Cleared
Jul 02, 2009
BIS CLICK SENSOR/CABLE
Neurology
13d
Cleared
Nov 20, 2007
BIS EEG VISTA MONITOR SYSTEM AND BISX
Neurology
96d
Cleared
Jun 18, 2007
BIS EEG MONITOR VIEW
Neurology
286d
Cleared
Feb 05, 2007
ZIPPREP ELECTRODE
Neurology
28d
Cleared
Dec 13, 2006
BIS BILATERAL SENSOR
Neurology
93d
Cleared
Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
Neurology
8d
Cleared
Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
Neurology
11d
Cleared
Feb 24, 2005
BIS SRS (SEMI-RESUABLE SENSOR)
Neurology
15d
Cleared
Jul 06, 2004
BIS PEDIATRIC SENSOR
Neurology
15d
Cleared
Feb 25, 2004
BISX
Neurology
29d
Cleared
Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
Neurology
353d
Cleared
Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
Neurology
88d
Cleared
Jul 10, 2001
BIS ENGINE
Neurology
28d
Cleared
Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
Neurology
28d
Cleared
Sep 27, 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
Neurology
90d
Cleared
Sep 19, 2000
BIS ENGINE
Neurology
7d
Cleared
Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
Neurology
13d
Cleared
Jan 18, 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
Neurology
26d
Cleared
Feb 06, 1998
A-2000 EEG MONITOR WITH BIS
Neurology
70d
Cleared
Oct 08, 1996
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
Neurology
26d
Cleared
Oct 04, 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
Neurology
147d
Cleared
Jan 16, 1996
A-1050 EEG MONITOR
Neurology
242d
Cleared
Dec 03, 1992
SPECTRAL EEG MONITOR MODEL A1000
Neurology
162d