Medical Device Manufacturer · US , Framingham , MA

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

25 submissions · 25 cleared · Since 1992

Total

Cleared

Denied

Aspect Medical Systems, Inc. has 25 FDA 510(k) cleared neurology devices. Based in Framingham, US.

Historical record: 25 cleared submissions from 1992 to 2009.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Aspect Medical Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

25 devices

1-25 of 25

BIS CLICK SENSOR/CABLE

K091854 · GXY

Neurology · 13d

Cleared Nov 20, 2007

BIS EEG VISTA MONITOR SYSTEM AND BISX

BIS EEG MONITOR, MODEL BISX4

K052981 · OLW

Neurology · 8d

Cleared Sep 09, 2005

BIS EEG MONITOR, MODEL A-3000

K052362 · OLW

Neurology · 11d

Cleared Feb 24, 2005

BIS SRS (SEMI-RESUABLE SENSOR)

EEG MONITOR WITH BIS, MODEL A-2000

K030267 · OLW

Neurology · 353d

Cleared Aug 29, 2003

MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

EEG MIS MONITOR MODEL # A-2000

K011534 · OLW

Neurology · 28d

Cleared Sep 27, 2000

ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106

K002734 · GXY

Neurology · 13d

Cleared Jan 18, 2000

ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

K994330 · GXY

Neurology · 26d

Cleared Feb 06, 1998

A-2000 EEG MONITOR WITH BIS

K974496 · OLW

Neurology · 70d

Cleared Oct 08, 1996

A-1000 EEG MONITOR AND A-1050 EEG MONITOR

K963644 · OLW

Neurology · 26d

Cleared Oct 04, 1996

ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR

Cardiovascular · 120d

Cleared Dec 03, 1992

SPECTRAL EEG MONITOR MODEL A1000

K923043 · OLT

Neurology · 162d

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

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

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