Simplified Sleep Stage Evaluation

Primary DI
04250413400744
Brand
Simplified Sleep Stage Evaluation
Company
SOMNOmedics AG
Model
SEP617
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
04250413400744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413400744042504134007444250413400744

GMDN Terms#

Term, Definition table
TermDefinition
Photoplethysmography/accelerometery recording sensorAn electrically-powered, wearable device (e.g., wristband, finger probe, head-worn sensor) designed to continuously measure and record: 1) photoplethysmography (PPG) data (e.g., pertaining to heart rate, respiration rate); and, 2) movement, during normal day- and/or night-time activities at home. It includes an optical PPG sensor and an accelerometer. The data is typically transferred to a local application or central database for analysis which includes evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
Kit
true
Lot or batch
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