OLW

Product Code: OLW

Products Classified as OLW

3768

Index-generating Electroencephalograph Software

Electroencephalograph.

Total Product Life Cycle (TPLC) Devices

3768

Index-generating Electroencephalograph Software

Electroencephalograph.

Pre-market Notifications for OLW

K203113	Masimo SedLine Sedation Monitor And Accessories	Masimo Corporation
K202621	NeuroSENSE Monitoring System, Model NS-901	NeuroWave Systems Inc.
K172890	SedLine Sedation Monitor	Masimo Corporation
K150298	Entropy Module, E-ENTROPY-01	GE HEALTHCARE FILAND OY
K083063	BIS INTERFACE FOR VITALOGIK PATIENT MONITORS	MENNEN MEDICAL LTD.
K072286	BIS EEG VISTA MONITOR SYSTEM AND BISX	ASPECT MEDICAL SYSTEMS, INC.
K071899	BIS MODULE FOR ENVOY PATIENT MONITOR	MENNEN MEDICAL LTD.
K062613	BIS EEG MONITOR VIEW	ASPECT MEDICAL SYSTEMS, INC.
K061907	MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES	GE HEALTHCARE
K060997	SNAP II EEG MONITOR	EVEREST BIOMEDICAL INSTRUMENTS CO.
K060900	SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842	SPACELABS MEDICAL INC.
K052981	BIS EEG MONITOR, MODEL BISX4	ASPECT MEDICAL SYSTEMS, INC.
K052362	BIS EEG MONITOR, MODEL A-3000	ASPECT MEDICAL SYSTEMS, INC.
K052145	DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES	GE HEALTHCARE
K051874	SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET	PHYSIOMETRIX, INC.

Global Unique Device Identification Database

• 90884521657515: Index-generating electroencephalograph software
• 10884521130111: Index-generating electroencephalograph software
• 06944904096728: Index-Generating Electroencephalograph Software
• 06936415905569: Index-Generating Electroencephalograph Software
• 10884521157545: Index-generating electroencephalograph software
• 10884521128774: Index-generating electroencephalograph software
• 10884521170247: Index-generating electroencephalograph software
• 10884521128859: Index-generating electroencephalograph software
• 10884521129658: Index-generating electroencephalograph software
• 10884521533097: Index-generating electroencephalograph software
• 00843997012485: Index-generating electroencephalograph software
• 10884521533080: Index-generating electroencephalograph software
• 10884521533127: Index-generating electroencephalograph software
• 00840682141291: Index-generating electroencephalograph software
• 10884521812369: Index-generating electroencephalograph software

Maude Adverse Events

BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2020-02-27
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2020-02-21
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	MMJ SA DE CV (USD)	2020-02-19
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2020-02-11
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT(SHANGHAI) LTD	2020-02-03
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2020-01-03
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2019-12-30
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	JABIL CIRCUIT SINGAPORE PTE LTD	2019-11-22
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	ASPECT MEDICAL	2019-11-12
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	ASPECT MEDICAL	2019-11-04
BISINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	ASPECT MEDICAL	2019-10-04
BIS	ASPECT MEDICAL	2018-12-07
BIS	JABIL CIRCUIT SINGAPORE PTE LTD	2018-12-05
BIS	ASPECT MEDICAL	2018-04-05
BISENDOSCOPIC TISSUE APPROXIMATION DEVICE	MALLINCKRODT MEDICAL	2017-12-22
BIS	COVIDIEN MFG PLAINFIELD	2017-07-19