FDA 510(k) Applications Submitted by ASPECT MEDICAL SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961821 |
05/10/1996 |
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
| K963644 |
09/12/1996 |
A-1000 EEG MONITOR AND A-1050 EEG MONITOR |
ASPECT MEDICAL SYSTEMS, INC. |
| K974496 |
11/28/1997 |
A-2000 EEG MONITOR WITH BIS |
ASPECT MEDICAL SYSTEMS, INC. |
| K994330 |
12/23/1999 |
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 |
ASPECT MEDICAL SYSTEMS, INC. |
| K030267 |
01/27/2003 |
EEG MONITOR WITH BIS, MODEL A-2000 |
ASPECT MEDICAL SYSTEMS, INC. |
| K040183 |
01/27/2004 |
BISX |
ASPECT MEDICAL SYSTEMS, INC. |
| K050313 |
02/09/2005 |
BIS SRS (SEMI-RESUABLE SENSOR) |
ASPECT MEDICAL SYSTEMS, INC. |
| K031694 |
06/02/2003 |
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 |
ASPECT MEDICAL SYSTEMS, INC. |
| K052362 |
08/29/2005 |
BIS EEG MONITOR, MODEL A-3000 |
ASPECT MEDICAL SYSTEMS, INC. |
| K052981 |
10/24/2005 |
BIS EEG MONITOR, MODEL BISX4 |
ASPECT MEDICAL SYSTEMS, INC. |
| K011534 |
05/18/2001 |
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
| K011834 |
06/12/2001 |
BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
| K001980 |
06/29/2000 |
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 |
ASPECT MEDICAL SYSTEMS, INC. |
| K002734 |
09/01/2000 |
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 |
ASPECT MEDICAL SYSTEMS, INC. |
| K002837 |
09/12/2000 |
BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
| K952347 |
05/19/1995 |
A-1050 EEG MONITOR |
ASPECT MEDICAL SYSTEMS, INC. |
| K041670 |
06/21/2004 |
BIS PEDIATRIC SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
| K062692 |
09/11/2006 |
BIS BILATERAL SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
| K070069 |
01/08/2007 |
ZIPPREP ELECTRODE |
ASPECT MEDICAL SYSTEMS, INC. |
| K091854 |
06/19/2009 |
BIS CLICK SENSOR/CABLE |
ASPECT MEDICAL SYSTEMS, INC. |
| K072286 |
08/16/2007 |
BIS EEG VISTA MONITOR SYSTEM AND BISX |
ASPECT MEDICAL SYSTEMS, INC. |
| K062613 |
09/05/2006 |
BIS EEG MONITOR VIEW |
ASPECT MEDICAL SYSTEMS, INC. |
| K093183 |
10/09/2009 |
BIS QUATRO SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
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