TPLC - Total Product Life Cycle

show TPLC since

Device	automatic event detection software for polysomnograph with electroencephalograph
Regulation Description	Electroencephalograph.
Definition	Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
Product Code	OLZ
Regulation Number	882.1400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED BRAIN MONITORING, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEACON BIOSIGNALS, INC.
	SUBSTANTIALLY EQUIVALENT	3
BRAIN ELECTROPHYSIOLOGY LABORATORY COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	1
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
EMBLA SYSTEMS
	SUBSTANTIALLY EQUIVALENT	3
ENSODATA, INC.
	SUBSTANTIALLY EQUIVALENT	2
HONEYNAPS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NATUS NEUROLOGY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NEUMETRY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROZONE MSH INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NOX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NOX MEDICAL EHF
	SUBSTANTIALLY EQUIVALENT	2
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	3	3
Insufficient Information	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
No Apparent Adverse Event	1	1
Computer Software Problem	1	2
Naturally Worn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5	6
Burn(s)	3	3
Superficial (First Degree) Burn	1	1
Deformity/ Disfigurement	1	1