FDA.reportPublic FDA data

Nurochek-Pro Server

Primary DI
09357225002038
Brand
Nurochek-Pro Server
Company
HEADSAFE MFG PTY LTD
Model
Nurochek-Pro Server (HS03-304)
Catalog number
HS03-304
Device description
The Nurochek-Pro Server is an umbrella term for backend software of the Nurochek-Pro System (HS03-369). It provides the functionality for all the data storage and processing required to support the Nurochek-Pro System. It facilitates the management of the System by providing secure website platforms for customers and Headsafe technicians to manage users, organizations, and files.
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243426000Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.2025-03-27PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09357225002038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09357225002038093572250020389357225002038

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61413133492support@team.headsafe.com

Regulatory Flags#

DUNS number
748905226
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09357225002014Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672026-03-18
09357225001017Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672025-12-15
09357225000041Nurochek-ProNurochek-Pro Kit (HS03-369) rev 2HS03-3692026-01-23
09357225000034Nurochek-ProNurochek-Pro Kit (HS03-369) rev 1HS03-3692025-12-15
09357225002021Nurochek-Pro Application Nurochek-Pro Application (HS03-303)2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitNurochek-Pro Soft Sensor Kit (HS03-313)HS03-3132025-12-15
09357225006029Nurochek-Pro Saline SolutionSaline Solution Bottle Assembly (HS03-368)HS03-3682025-12-15

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Primary DI, Brand, Company table
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