Zmachine

Primary DI
B566847002
Brand
Zmachine
Company
General Sleep
Model
Synergy
Device description
Zmachine Synergy in-home sleep testing device.
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172986000Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO2017-12-19OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B566847002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device.

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
B5663000010ZmachineSynergy2018-03-01
B5662000010ZmachineInsight/Insight+2018-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15