FDA.reportPublic FDA data

Xltek

Primary DI
00382830061742
Brand
Xltek
Company
XLTEK
Model
041904
Device description
NeuroWorks/SleepWorks 10.0.1 Software (US)
Published
2023-07-26
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
OMAAmplitude-Integrated Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMAAmplitude-Integrated ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180421000Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-14OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830061742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830061742003828300617423828300617420382830061742

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245258280
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830023955Natus20130012025-02-27
00382830023986Natus20400012025-02-27
00382830059251Natus20200112025-02-27
00382830062466Natus60-0000702024-09-30
00382830016896Natus61-0004002021-06-22
00382830056335Natus61-0003002021-06-22
00382830058674Natus60-0000902021-06-22
00382830058681Natus60-0000922021-06-22
00382830060110NatusRETCAM-FA-UPGRADE2021-06-22
00382830002424Natus103282016-09-13
00382830002950Natus103592016-09-13
00382830003063Natus1027622016-09-13
00382830003155Natus1040372016-09-13
00382830022316GrassCMXL-PLUS-ECMXL-PLUS-E2018-07-13
00382830022323GrassCMXL-E-SPCCMXL-E-SPC2018-07-13
00382830022330GrassCMXL-E-APCCMXL-E-APC2018-07-13
00382830022347GrassCM-PLUS-ECM-PLUS-E2018-07-13
00382830022392GrassCMXL-PLUS-PCMXL-PLUS-P2018-07-13
00382830022408GrassCMXL-P-NCCMXL-P-NC2018-07-13
00382830022415GrassCMXL-P-APCCMXL-P-APC2018-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOMA2026-05-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMA2025-04-04
00382830057745XltekXLTEKOMA2024-04-19
00382830061902XltekXLTEKOMA2024-04-19
10197106549971CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
50197106549979CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
00382830063067XltekXLTEKOMA2023-08-23
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDOMA2023-08-18
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830059541XltekXLTEKOMA2023-07-26
00382830061766XltekXLTEKOMA2023-07-26
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMA2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMA2022-07-15
00382830008679NatusXLTEKOMA2021-10-26
00382830007450NatusXLTEKOMA2021-10-07
00382830007443NatusXLTEKOMA2021-10-07
00382830058209NatusXLTEKOMA2021-04-20
00382830058216NatusXLTEKOMA2021-04-20
00382830058575NatusXLTEKOMA2021-04-20
B485CNSPTZ3501Component Monitoring SystemMOBERG RESEARCH INCOMA2021-04-19
B485CNS3501Component Neuromonitoring SystemMOBERG RESEARCH INCOMA2021-02-12
09120109830078encevisAIT Austrian Institute of Technology GmbHOMA2021-01-11
B485CNSVID3501Component Monitoring SystemMOBERG RESEARCH INCOMA2020-10-31