Medical Device Manufacturer · US , Framingham , MA

Aspect Medical Systems, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1992

25

Total

25

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aspect Medical Systems, Inc. Neurology ✕

24 devices

1-12 of 24

Cleared Oct 23, 2009

BIS QUATRO SENSOR

Neurology · 14d

Cleared Jul 02, 2009

BIS CLICK SENSOR/CABLE

Neurology · 13d

Cleared Nov 20, 2007

BIS EEG VISTA MONITOR SYSTEM AND BISX

Neurology · 96d

Cleared Jun 18, 2007

BIS EEG MONITOR VIEW

Neurology · 286d

Cleared Feb 05, 2007

ZIPPREP ELECTRODE

Neurology · 28d

Cleared Dec 13, 2006

BIS BILATERAL SENSOR

Neurology · 93d

Cleared Nov 01, 2005

BIS EEG MONITOR, MODEL BISX4

Neurology · 8d

Cleared Sep 09, 2005

BIS EEG MONITOR, MODEL A-3000

Neurology · 11d

Cleared Feb 24, 2005

BIS SRS (SEMI-RESUABLE SENSOR)

Neurology · 15d

Cleared Jul 06, 2004

BIS PEDIATRIC SENSOR

Neurology · 15d

Cleared Feb 25, 2004

Neurology · 29d

Cleared Jan 15, 2004

EEG MONITOR WITH BIS, MODEL A-2000

Neurology · 353d