Aspect Medical Systems, Inc.
FDA 510(k) & PMA Approved Devices — 25 products
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Total Devices25
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K093183 | BIS QUATRO SENSOR | GXY | 2009-10-23 | View |
| 510(k) | K091854 | BIS CLICK SENSOR/CABLE | GXY | 2009-07-02 | View |
| 510(k) | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | 2007-11-20 | View |
| 510(k) | K062613 | BIS EEG MONITOR VIEW | OLW | 2007-06-18 | View |
| 510(k) | K070069 | ZIPPREP ELECTRODE | GXY | 2007-02-05 | View |
| 510(k) | K062692 | BIS BILATERAL SENSOR | GXY | 2006-12-13 | View |
| 510(k) | K052981 | BIS EEG MONITOR, MODEL BISX4 | OLW | 2005-11-01 | View |
| 510(k) | K052362 | BIS EEG MONITOR, MODEL A-3000 | OLW | 2005-09-09 | View |
| 510(k) | K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | GWY | 2005-02-24 | View |
| 510(k) | K041670 | BIS PEDIATRIC SENSOR | GXY | 2004-07-06 | View |
| 510(k) | K040183 | BISX | OLW | 2004-02-25 | View |
| 510(k) | K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | OLW | 2004-01-15 | View |
| 510(k) | K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | OLW | 2003-08-29 | View |
| 510(k) | K011834 | BIS ENGINE | OLW | 2001-07-10 | View |
| 510(k) | K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | OLW | 2001-06-15 | View |
| 510(k) | K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 | GXY | 2000-09-27 | View |
| 510(k) | K002837 | BIS ENGINE | OLW | 2000-09-19 | View |
| 510(k) | K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | GXY | 2000-09-14 | View |
| 510(k) | K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | GXY | 2000-01-18 | View |
| 510(k) | K974496 | A-2000 EEG MONITOR WITH BIS | OLW | 1998-02-06 | View |
No matching devices.
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