FDA 510(k) Applications Submitted by CHRISTINE M VOZELLA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
|
|
