FDA.reportPublic FDA data

Polysmith Version 11.0

Primary DI
00817111020779
Brand
Polysmith Version 11.0
Company
Neurotronics, LLC
Model
11.0
Published
2017-03-10
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
DQAOximeter
GWLAmplifier, Physiological Signal
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
MNRVentilatory Effort Recorder
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
GWLAmplifier, Physiological SignalNeurology2
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062943000POLYSMITH SLEEP SYSTEM, MODEL NTI5498Neurotronics, Inc.2007-05-09OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111020779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111020779008171110207798171110207790817111020779

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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817111021288NiteLynx PVDF Effort Sensor1.5mm DIN, 0.6mS203402025-10-10
00817111021295NiteLynx PVDF Effort Sensor1.5mm DIN, 2.0mS829672025-10-10
00817111021301NiteLynx PVDF Effort Sensor249 Keyhole, 0.6mS687292025-10-10
00817111021318NiteLynx PVDF Effort Sensor249 Keyhole, 2.0mS681592025-10-10
00817111021325NiteLynx PVDF Effort SensorDisposable BeltS618152025-10-10
00817111021349NiteLynx PVDF Effort SensorNomadAirS922732025-10-10
00817111021332Polysmith12.32025-09-23
00817111021158Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0mPZ01S528972019-05-01
00817111021165Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0mPZ01S831112019-05-01
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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