FDA.reportPublic FDA data

Blackrock NeuroPort Biopotential Signal Processing System

Primary DI
00814901020193
Brand
Blackrock NeuroPort Biopotential Signal Processing System
Company
BLACKROCK MICROSYSTEMS, LLC
Model
6.5.4
Catalog number
RS-0049
Device description
NeuroPort Central Suite
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090957000BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEMI2s Micro Implantable Systems, LLC2009-05-28GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814901020193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814901020193008149010201938149010201930814901020193

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18015825533support@blackrockmicro.com

Regulatory Flags#

DUNS number
827132015
Device count
1
Lot or batch
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
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
00814901021534Digital NeuroPort Biopotential Signal Processing System12125121252023-12-04
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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