Aspect Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BIS QUATRO SENSOR, BIS CLICK SENSOR/CABLE, BIS EEG VISTA MONITOR SYSTEM AND BISX
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