FDA.reportPublic FDA data

Live View Panel Version 1.3

Primary DI
00817111020786
Brand
Live View Panel Version 1.3
Company
Neurotronics, LLC
Model
1.3
Device description
Live View Panel Version 1.3
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLVStandard Polysomnograph With Electroencephalograph
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131415000LIVE VIEW PANEL (LVP)Neurotronics, Inc.2013-08-09OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817111020786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817111020786008171110207868171110207860817111020786

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

Regulatory Flags#

DUNS number
036405363
Device count
1
Lot or batch
true

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