FDA.reportPublic FDA data

SPARK Neuro

Primary DI
00860011882015
Brand
SPARK Neuro
Company
Spark Neuro Inc.
Model
SP000000
Published
2025-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231457000SPARK ScanSpark Neuro, Inc.2023-08-18GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011882015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011882015008600118820158600118820150860011882015

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

Contacts#

Phone, Email table
PhoneEmail
(332) 273-0300info@sparkneuro.com

Regulatory Flags#

DUNS number
963556142
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011882022SPARK Neuro SP0100002025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B675ONEHUL0Zeto ONE Head Unit - RegularZETO INCGWQ2026-03-13
B675ONEHUS0Zeto ONE Head Unit - SmallZETO INCGWQ2026-03-13
04931921877401BluPRO®NIHON KOHDEN CORPORATIONGWQ2026-02-03
B675ONEHUL1Zeto ONE Head Unit - RegularZETO INCGWQ2025-07-09
B675ONEHUS1Zeto ONE Head Unit - SmallZETO INCGWQ2025-07-09
00382830059572NatusXLTEKGWQ2025-04-02
00382830059923NatusXLTEKGWQ2025-04-02
00850063034104X-SeriesADVANCED BRAIN MONITORING, INC.GWQ2024-12-19
B675DC0Zeto ONE Disinfection Container with LidZETO INCGWQ2024-11-20
B675MM0Zeto All-in-One Medical Grade PCZETO INCGWQ2024-11-20
09355751001174Seer HomeSEER MEDICAL HOLDINGS LIMITEDGWQ2024-06-27
09355751001181Seer HomeSEER MEDICAL HOLDINGS LIMITEDGWQ2024-06-27
09355751001228Seer HomeSEER MEDICAL HOLDINGS LIMITEDGWQ2024-06-27
09355751001235Seer HomeSEER MEDICAL HOLDINGS LIMITEDGWQ2024-06-27
09355751001242Seer HomeSEER MEDICAL HOLDINGS LIMITEDGWQ2024-06-27
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWQ2024-06-21
B675ONEAUX1Zeto ONE AUX Cable Extension SetZETO INCGWQ2024-06-11
B675ONEDU0Zeto ONE Display UnitZETO INCGWQ2024-06-11
B675ONEEMG1Zeto ONE EMG Cable Extension SetZETO INCGWQ2024-06-11
B675ONEHEOG1Zeto ONE HEOG Cable Extension SetZETO INCGWQ2024-06-11
B675ONEHU1Zeto ONE Head UnitZETO INCGWQ2024-06-11
B675ONEREF1Zeto ONE REF Cable ExtensionZETO INCGWQ2024-06-11
B675ONEVEOG1Zeto ONE VEOG Cable Extension SetZETO INCGWQ2024-06-11
05061027610011Cumulus Functional Neurophysiology PlatformCUMULUS NEUROSCIENCE LIMITEDGWQ2024-06-05
03615220003679Neuronaute Plus Touchproof ExtenderBIOSERENITY MEDICAL DEVICES GROUPGWQ2024-05-22
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCGWQ2024-05-09
00382830047425XltekXLTEKGWQ2024-04-11
00382830058056NatusXLTEKGWQ2024-04-02
03615220003983Neuronaute Plus- Holding BandBIOSERENITY MEDICAL DEVICES GROUPGWQ2024-03-21
00382830048149NatusXLTEKGWQ2024-03-20