Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
index-generating electroencephalograph software
Definition
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Product Code
OLW
Regulation Number
882.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORTICAL DYNAMICS LTD
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FILAND OY
SUBSTANTIALLY EQUIVALENT
1
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
2
NEUROWAVE SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
3
3
2018
3
3
2019
6
6
2020
15
15
2021
15
15
2022
27
27
2023
18
18
2024
61
61
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
46
46
Temperature Problem
26
26
High Readings
25
25
Low Readings
12
12
Image Display Error/Artifact
10
10
Increase in Pressure
10
10
Device Damaged Prior to Use
9
9
Device Alarm System
8
8
Erratic or Intermittent Display
5
5
Appropriate Term/Code Not Available
5
5
Material Split, Cut or Torn
4
4
Patient Device Interaction Problem
4
4
Failure to Power Up
4
4
No Apparent Adverse Event
4
4
Use of Device Problem
3
3
Data Problem
3
3
Computer Software Problem
3
3
Noise, Audible
3
3
Smoking
2
2
Defective Component
2
2
Device Emits Odor
2
2
Connection Problem
2
2
Failure to Analyze Signal
2
2
Failure to Run on Battery
2
2
Fitting Problem
1
1
Fire
1
1
Communication or Transmission Problem
1
1
Insufficient Information
1
1
No Audible Alarm
1
1
Unable to Obtain Readings
1
1
No Audible Prompt/Feedback
1
1
High Test Results
1
1
Protective Measures Problem
1
1
Image Orientation Incorrect
1
1
Overheating of Device
1
1
Display or Visual Feedback Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
66
66
Insufficient Information
57
57
No Consequences Or Impact To Patient
9
9
No Patient Involvement
5
5
No Known Impact Or Consequence To Patient
3
3
Injury
3
3
Skin Inflammation/ Irritation
2
2
Oversedation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
No Code Available
1
1
Cardiac Arrest
1
1
Awareness during Anaesthesia
1
1
Pressure Sores
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
Aug-30-2018
-
-