Aspect Medical Systems, Inc.
Newton, MA, US
Aspect Medical Systems, Inc. appears in FDA device records in Newton, MA. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Aspect Medical Systems, Inc. between 1992 and 2009. The busiest year on record is 2000, with 4. The most recent is 2009, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 1996 | 3 |
| 1998 | 1 |
| 2000 | 4 |
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093183 | BIS QUATRO SENSOR | GXY | Substantially Equivalent | |
| K091854 | BIS CLICK SENSOR/CABLE | GXY | Substantially Equivalent | |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | Substantially Equivalent | |
| K062613 | BIS EEG MONITOR VIEW | OLW | Substantially Equivalent | |
| K070069 | ZIPPREP ELECTRODE | GXY | Substantially Equivalent | |
| K062692 | BIS BILATERAL SENSOR | GXY | Substantially Equivalent | |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | OLW | Substantially Equivalent | |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | OLW | Substantially Equivalent | |
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | GWY | Substantially Equivalent | |
| K041670 | BIS PEDIATRIC SENSOR | GXY | Substantially Equivalent | |
| K040183 | BISX | OLW | Substantially Equivalent | |
| K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | OLW | Substantially Equivalent | |
| K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | OLW | Substantially Equivalent | |
| K011834 | BIS ENGINE | OLW | Substantially Equivalent | |
| K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | OLW | Substantially Equivalent | |
| K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 | GXY | Substantially Equivalent | |
| K002837 | BIS ENGINE | OLW | Substantially Equivalent | |
| K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | GXY | Substantially Equivalent | |
| K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | GXY | Substantially Equivalent | |
| K974496 | A-2000 EEG MONITOR WITH BIS | OLW | Substantially Equivalent | |
| K963644 | A-1000 EEG MONITOR AND A-1050 EEG MONITOR | OLW | Substantially Equivalent | |
| K961821 | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR | GXY | Substantially Equivalent | |
| K952347 | A-1050 EEG MONITOR | OLT | Substantially Equivalent | |
| K940802 | ZIPPREP ELECTRODE | DRX | Substantially Equivalent | |
| K923043 | SPECTRAL EEG MONITOR MODEL A1000 | OLT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain