FDA.reportPublic FDA data

Enobio Dx

Primary DI
18437017440687
Brand
Enobio Dx
Company
NEUROELECTRICS BARCELONA SL
Model
NG Pistim - Component Spare Part: Enobio Dx
Device description
This device is the spare part of Enobio Dx's component NG Pistim. NG Pistim is an EEG electrode to be used with Enobio Dx.Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording.
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162681000Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.2017-06-02GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18437017440687PrimaryGS10
08437017440406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843701744068718437017440687
08437017440406084370174404068437017440406

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+34 932540366support@neuroelectrics.com

Regulatory Flags#

DUNS number
463756944
Device count
8
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18436612824038Enobio DxTouchproof Adapter 8 - Component Spare Part: Enobi2026-09-18
18436612824045Enobio DxTouchproof Adapter 20 - Component Spare Part: Enob2026-09-18
18436612824052Enobio DxTouchproof Adapter 32 - Component Spare Part: Enob2026-09-18
18437017440601Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440632Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440663Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18436612823031Enobio DxNeoprene Headcap (size L) - Component Spare Part: 2023-09-14
18436612823048Enobio DxNeoprene Headcap (size M) - Component Spare Part: 2023-09-14
18436612823055Enobio DxNeoprene Headcap (size S) - Component Spare Part: 2023-09-14
18436612823062Enobio DxNeoprene Headcap (size XL) - Component Spare Part:2023-09-14
18436612823079Enobio DxNeoprene Headband - Component Spare Part: Enobio D2023-09-14
08437017440390Enobio DxDrytrode - Component Spare Part: Enobio Dx2023-09-14
18437017440618Enobio DxEarclip - Component Replacement: Enobio Dx2023-09-14
18437017440625Enobio DxForetrode - Component Replacement: Enobio Dx2023-09-14
08437017440383Enobio DxForetrode - Component Spare Part: Enobio Dx2023-09-14
18437017440656Enobio DxNG Geltrode - Component Replacement: Enobio Dx2023-09-14
08437017440376Enobio DxNG Geltrode - Component Spare Part: Enobio Dx2023-09-14
18437017440670Enobio DxNG Pistim - Component Replacement: Enobio Dx2023-09-14
08437017440406Enobio DxNG Pistim - Component Spare Part: Enobio Dx2023-09-14
18436612823000Enobio DxNeoprene Headcap (Kit, size M) - Component Replace2023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWL2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
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08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
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08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
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