TPLC - Total Product Life Cycle

show TPLC since

Device	automatic event detection software for full-montage electroencephalograph
Regulation Description	Electroencephalograph.
Definition	Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Product Code	OMB
Regulation Number	882.1400
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
	SUBSTANTIALLY EQUIVALENT	1
AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
	SUBSTANTIALLY EQUIVALENT	1
CERIBELL, INC.
	SUBSTANTIALLY EQUIVALENT	2
EPITEL, INC
	SUBSTANTIALLY EQUIVALENT	1
EPITEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOLBERG EEG AS
	SUBSTANTIALLY EQUIVALENT	2
LVIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
	SUBSTANTIALLY EQUIVALENT	1
PERSYST DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PERSYST DEVELOPMENT LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Crack	9	9
Unintended Movement	6	6
Break	5	5
Use of Device Problem	4	4
Physical Resistance/Sticking	3	3
Device Fell	3	3
Application Program Problem	2	2
Material Twisted/Bent	2	2
Sparking	1	1
Component or Accessory Incompatibility	1	1
Mechanical Problem	1	1
Communication or Transmission Problem	1	1
Computer Software Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Cardiac Arrest	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)	II	Feb-22-2022