SOMNOscreen HD PSG

Primary DI
04250413410644
Brand
SOMNOscreen HD PSG
Company
SOMNOmedics AG
Model
NGD201AU
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071556000SOMNOSCREEN EEG10-20Somnomedics GmbH2007-07-18MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413410644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413410644042504134106444250413410644

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
042504134004853-channel ECG ElectrodeSEP6282026-10-09
04250413402380Pneumatic Effort Belt - Size XSSEN6412026-10-09
04250413402397Pneumatic Effort Belt - Size SSEN6422026-10-09
04250413402403Pneumatic Effort Belt - Size MSEN6432026-10-09
04250413402410Pneumatic Effort Belt - Size LSEN6442026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSEN6452026-10-09
04250413407392Sensor kit for SOMNOscreen (paediatric)SEN8002026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SEN8012026-10-10
04250413410392Wireless PLM/EMG sensor right legNGS0752026-10-08
04250413401635DOMINO lightSOW1052026-10-07
04250413402861EEG-ElectrodeSEN0072026-10-07
04250413404858SOMNOtouchâ„¢ RESP ecoTOR050-E-U2026-10-07
04250413405657ABPMpro SoftwareSW1002026-10-07
04250413405664DOMINOSSC0902026-10-07
04250413410385Wireless PLM/EMG sensor left legNGS0742026-10-07
04250413405725HomeSleepTestHST050U2026-07-02
04250413405732HomeSleepTest REM+HSTR050U2026-07-02
04250413410637SOMNOscreen HDNGD050U2026-08-13
04250413402724SOMNOscreen ecoNGN050U2019-03-15
04250413403578Cuff ABPMpro without ECGABP501/B2026-07-07