FDA.reportPublic FDA data

COMBY EEG CAP

Primary DI
03858894151950
Brand
COMBY EEG CAP
Company
PAMEL d.o.o.
Model
Comby EEG Cap/ 22 Ag/AgCl EL.
Catalog number
CEC1224752
Device description
Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 47-52
Published
2022-08-16
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
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211315000Comby EEG CapsPamel D.O.O2021-11-09GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03858894151950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03858894151950038588941519503858894151950

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, reusableAn array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
643949162
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03858894154500COMBY EEG CAPChest belt for EEG cap for adults, LBFRA_L2025-02-28
03858894154517COMBY EEG CAPChest belt for EEG cap for adults, MBFRA_M2025-02-28
03858894154524COMBY EEG CAPChest belt for EEG cap for adults, SBFRA_S2025-02-28
03858894152810COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13447522023-08-16
03858894152827COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13452572023-08-16
03858894152834COMBY EEG CAPComby EEG Cap/ 34 Ag/AgCl EL. CEC13457622023-08-16
03858894153398COMBY EEG CAPBypass electrodes Ag/AgClBYP102023-08-16
03858894153411COMBY EEG CAPBypass electrodes Ag/AgCl, greenBYP10G2023-08-16
03858894153428COMBY EEG CAPBypass electrodes Ag/AgCl, redBYP10R2023-08-16
03858894153442COMBY EEG CAPBypass electrodes Ag/AgCl, yellowBYP10Y2023-08-16
03858894154135COMBY EEG CAPChest belt for EEG cap for adultsBFRA2023-08-16
03858894153183COMBY EEG CAPELECUP120 - CUP Ag/AgCl electrodeELECUP5SET1202022-08-16
03858894151967COMBY EEG CAPComby EEG Cap/ 22 Ag/AgCl EL. CEC12252572022-08-16
03858894151974Comby EEG CapComby EEG Cap/ 22 Ag/AgCl EL. CEC12257622022-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02