Company ยท US
Aspect Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2009. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2009 | K093183 | BIS QUATRO SENSOR Aspect Medical Systems, Inc. | GXY |
| Jul 2, 2009 | K091854 | BIS CLICK SENSOR/CABLE Aspect Medical Systems, Inc. | GXY |
| Nov 20, 2007 | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX Aspect Medical Systems, Inc. | OLW |
| Jun 18, 2007 | K062613 | BIS EEG MONITOR VIEW Aspect Medical Systems, Inc. | OLW |
| Feb 5, 2007 | K070069 | ZIPPREP ELECTRODE Aspect Medical Systems, Inc. | GXY |
| Dec 13, 2006 | K062692 | BIS BILATERAL SENSOR Aspect Medical Systems, Inc. | GXY |
| Nov 1, 2005 | K052981 | BIS EEG MONITOR, MODEL BISX4 Aspect Medical Systems, Inc. | OLW |
| Sep 9, 2005 | K052362 | BIS EEG MONITOR, MODEL A-3000 Aspect Medical Systems, Inc. | OLW |
| Feb 24, 2005 | K050313 | BIS SRS (SEMI-RESUABLE SENSOR) Aspect Medical Systems, Inc. | GWY |
| Jul 6, 2004 | K041670 | BIS PEDIATRIC SENSOR Aspect Medical Systems, Inc. | GXY |
| Feb 25, 2004 | K040183 | BISX Aspect Medical Systems, Inc. | OLW |
| Jan 15, 2004 | K030267 | EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. | OLW |
| Aug 29, 2003 | K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. | OLW |
| Jul 10, 2001 | K011834 | BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Jun 15, 2001 | K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Sep 27, 2000 | K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 Aspect Medical Systems, Inc. | GXY |
| Sep 19, 2000 | K002837 | BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Sep 14, 2000 | K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 Aspect Medical Systems, Inc. | GXY |
| Jan 18, 2000 | K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 Aspect Medical Systems, Inc. | GXY |
| Feb 6, 1998 | K974496 | A-2000 EEG MONITOR WITH BIS Aspect Medical Systems, Inc. | OLW |
| Oct 8, 1996 | K963644 | A-1000 EEG MONITOR AND A-1050 EEG MONITOR Aspect Medical Systems, Inc. | OLW |
| Oct 4, 1996 | K961821 | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR Aspect Medical Systems, Inc. | GXY |
| Jan 16, 1996 | K952347 | A-1050 EEG MONITOR Aspect Medical Systems, Inc. | OLT |
| Jun 22, 1994 | K940802 | ZIPPREP ELECTRODE Aspect Medical Systems, Inc. | DRX |
| Dec 3, 1992 | K923043 | SPECTRAL EEG MONITOR MODEL A1000 Aspect Medical Systems, Inc. | OLT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||