FDA.reportPublic FDA data

Natus

Primary DI
00382830002820
Brand
Natus
Company
XLTEK
Model
10397
Device description
BRAINMONITOR W/O OXIMETER
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042223000XLTEK CONNEX IP HEADBOX, MODEL 1054Excel Tech. , Ltd.2004-09-16OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830002820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830002820003828300028203828300028200382830002820

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245258280
Device count
1
Serial number
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 CORPORATIONOMB2026-05-12
05060941990018AutoscoreHolberg Eeg ASOMB2026-01-28
09120109830269encevisAIT Austrian Institute of Technology GmbHOMB2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMB2025-04-04
00860005388189REMI VigilenzEpitel, Inc.OMB2024-03-11
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMB2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMB2022-07-15
00382830058506NatusXLTEKOMB2021-10-07
00382830007443NatusXLTEKOMB2021-10-07
00851420007052Pocket EEG DeviceCERIBELL, INC.OMB2021-08-02
00382830058209NatusXLTEKOMB2021-04-20
00382830058216NatusXLTEKOMB2021-04-20
00382830058575NatusXLTEKOMB2021-04-20
09120109830078encevisAIT Austrian Institute of Technology GmbHOMB2021-01-11
00382830008020NatusXLTEKOMB2019-11-27
00382830010924NatusXLTEKOMB2019-11-27
00869732000128Persyst 14 Review and Analysis SoftwarePersyst Development CorpOMB2019-04-08
00869732000135Persyst Mobile App Persyst Development CorpOMB2019-04-08
00869732000142Persyst Mobile AppPersyst Development CorpOMB2019-04-08
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareCERIBELL, INC.OMB2018-03-28
00382830022231XLTEKXLTEKOMB2016-10-17
00382830002493NatusXLTEKOMB2016-09-13
00382830002516NatusXLTEKOMB2016-09-13
00382830002523NatusXLTEKOMB2016-09-13
00382830002547NatusXLTEKOMB2016-09-13
00382830002554NatusXLTEKOMB2016-09-13
00382830002677NatusXLTEKOMB2016-09-13
00382830002745NatusXLTEKOMB2016-09-13
00382830009072NatusXLTEKOMB2016-09-13
00382830016643NatusXLTEKOMB2016-09-13