Zmachine

Primary DI
B5662000010
Brand
Zmachine
Company
General Sleep
Model
Insight/Insight+
Published
2018-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142825000ZmachineConsolidated Research of Richmond, Inc.2015-01-20OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5662000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(216) 289-2331support@generalsleep.com

Regulatory Flags#

DUNS number
860092022
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B566847020ZmachineInsight/Insight+2026-04-16
B566847001ZmachineSynergy2026-04-09
B566847002ZmachineSynergy2026-04-09
B5663000010ZmachineSynergy2018-03-01

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Primary DI, Brand, Company table
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