Zmachine

GUDID B5662000010

Electroencephalographic monitoring system, portable

Primary Device ID	B5662000010
NIH Device Record Key	0715c2ac-a894-4904-b57d-bd597a2598e4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Zmachine
Version Model Number	Insight/Insight+
Company DUNS	860092022
Company Name	General Sleep
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B5662000010 [Primary]

OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

B5663000010	Synergy
B5662000010	Insight/Insight+

Mark Image Registration \| Serial	Company Trademark Application Date
ZMACHINE 77064956 3370019 Live/Registered	Consolidated Research of Richmond, Inc. 2006-12-15