FDA.reportPublic FDA data

NiteLynx PVDF Effort Sensor

Primary DI
00817111021288
Brand
NiteLynx PVDF Effort Sensor
Company
Neurotronics, LLC
Model
1.5mm DIN, 0.6m
Catalog number
S20340
Device description
NiteLynx PVDF Effort Sensor, 1.5mm DIN, 0.6m
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SFKRespiratory Effort Belt For Polysomnography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFKRespiratory Effort Belt For PolysomnographyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251480000PV01 PVDF Effort SensorNeurotronics, LLC2025-08-29SFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111021288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111021288008171110212888171110212880817111021288

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.

Regulatory Flags#

DUNS number
036405363
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817111020939"Serenity RIP01 RIP Belt, Small - 15""-27"""RIP01S770382018-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817111021295NiteLynx PVDF Effort SensorNeurotronics, LLCSFK2025-10-10
00817111021301NiteLynx PVDF Effort SensorNeurotronics, LLCSFK2025-10-10
00817111021318NiteLynx PVDF Effort SensorNeurotronics, LLCSFK2025-10-10
00817111021325NiteLynx PVDF Effort SensorNeurotronics, LLCSFK2025-10-10
00817111021349NiteLynx PVDF Effort SensorNeurotronics, LLCSFK2025-10-10