FDA.reportPublic FDA data

Live View Panel Version 1.4

Primary DI
00817111020816
Brand
Live View Panel Version 1.4
Company
Neurotronics, LLC
Model
1.4
Device description
Live View Panel Version 1.4
Published
2017-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131415000LIVE VIEW PANEL (LVP)Neurotronics, Inc.2013-08-09OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111020816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111020816008171110208168171110208160817111020816

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive softwareAn interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036405363
Device count
1
Lot or batch
true

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00817111021318NiteLynx PVDF Effort Sensor249 Keyhole, 2.0mS681592025-10-10
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00817111021332Polysmith12.32025-09-23
00817111021158Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0mPZ01S528972019-05-01
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00817111020823Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0mBP01S179262018-11-08
00817111020830Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0mBP01S297242018-11-08
00817111020847Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0mBP01S407122018-11-08
00817111020854Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6mRIP01S433592018-11-08
00817111020861Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0mRIP01S531072018-11-08
00817111020878Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.6mRIP01S849962018-11-08
00817111020885Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 2.0mRIP01S330592018-11-08
00817111020892Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0mRIP01S734262018-11-08
00817111020908Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6mRIP01S391542018-11-08
00817111020915Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6mRIP01S556382018-11-08
00817111020922Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 2.0mRIP01S215762018-11-08

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