FDA.reportPublic FDA data

Digital NeuroPort Biopotential Signal Processing System

Primary DI
00814901021534
Brand
Digital NeuroPort Biopotential Signal Processing System
Company
BLACKROCK MICROSYSTEMS, LLC
Model
12125
Catalog number
12125
Device description
Gemini Neural Signal Processor
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWKConditioner, Signal, Physiological
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWKConditioner, Signal, PhysiologicalNeurology2
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202174000Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems2021-02-10GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814901021435PreviousGS10
00814901021534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814901021435008149010214358149010214350814901021435
00814901021534008149010215348149010215340814901021534

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8015825533mtrebella@blackrockneuro.com

Regulatory Flags#

DUNS number
827132015
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814901021541Digital NeuroPort Biopotential Signal Processing System13178131782025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing System7.7.0RS-00492025-02-14
00814901021466Blackrock NeuroPort Biopotential Signal Processing System7.6.0RS-00492023-05-17
00814901021459Blackrock NeuroPort Biopotential Signal Processing System7.5.2RS-0049, RS-01522022-09-27
00814901021435Digital NeuroPort Biopotential Signal Processing System12125121252022-09-20
00814901021442Digital NeuroPort Biopotential Signal Processing System12126121262022-09-20
00814901021428Blackrock NeuroPort Biopotential Signal Processing System7.5.0RS-00492022-08-11
00814901020001NeuroPort Electrode438243822016-09-23
00814901021411Digital NeuroPort Biopotential Signal Processing System13177131772021-11-24
00814901020193Blackrock NeuroPort Biopotential Signal Processing System6.5.4RS-00492016-09-23
00814901020278Blackrock NeuroPort Biopotential Signal Processing System7.0.0RS-00492017-07-05
00814901020100Blackrock NeuroPort Biopotential Signal Processing System446044602016-10-13
00814901020117Blackrock NeuroPort Biopotential Signal Processing System673567352017-02-14
00814901021527Digital NeuroPort Biopotential Signal Processing System12126121262023-12-04
00814901021497Blackrock NeuroPort Biopotential Signal Processing System7.6.1RS-00492023-07-14
00814901021473NeuroPlex E12812889128892023-05-18
00814901021480NeuroPlex E128 Sterile12890128902023-05-18
00814901020292Blackrock NeuroPort Biopotential Signal Processing System7.0.2RS-01012018-09-06
00814901020308Blackrock NeuroPort Biopotential Signal Processing System7.0.3RS-01012018-09-06
00814901020315Blackrock NeuroPort Biopotential Signal Processing System7.0.4RS-01152018-09-06

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08056446901090NExT Station AdvancedEB NEURO SPAGWL2025-05-19
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