Aspect Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 25
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K093183 | BIS QUATRO SENSOR | October 23, 2009 |
| K091854 | BIS CLICK SENSOR/CABLE | July 2, 2009 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | November 20, 2007 |
| K062613 | BIS EEG MONITOR VIEW | June 18, 2007 |
| K070069 | ZIPPREP ELECTRODE | February 5, 2007 |
| K062692 | BIS BILATERAL SENSOR | December 13, 2006 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | November 1, 2005 |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | September 9, 2005 |
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | February 24, 2005 |
| K041670 | BIS PEDIATRIC SENSOR | July 6, 2004 |
| K040183 | BISX | February 25, 2004 |
| K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | January 15, 2004 |
| K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | August 29, 2003 |
| K011834 | BIS ENGINE | July 10, 2001 |
| K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | June 15, 2001 |
| K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 | September 27, 2000 |
| K002837 | BIS ENGINE | September 19, 2000 |
| K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | September 14, 2000 |
| K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | January 18, 2000 |
| K974496 | A-2000 EEG MONITOR WITH BIS | February 6, 1998 |