FDA.reportPublic FDA data

SleepScout

Primary DI
B14350101320
Brand
SleepScout
Company
Cleveland Medical Devices Inc.
Model
Computer Unit
Catalog number
502-0132
Device description
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
Published
2016-09-23
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042039000FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120Cleveland Medical Devices, Inc.2004-11-17OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14350101320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557510625
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14350100280SleepScoutXPOD Interface501-00282016-09-26
B143502014610SleepScoutSleepScout Mobile Unit502-0146-12016-09-23
B14350201490SleepScoutComputer Unit502-01492016-09-23
B14360200511SleepScoutOptional Sensor Kit602-00512016-09-23
B14360201292SleepScoutInternational Sensor Kit602-01292016-09-23
B143700000712SleepScout Starter KitStandard700-0007-12016-09-23
B14360201201Premium Study KitTwo Belt - Large602-01202016-09-23
B14360201231Premium Study KitTwo Belt - XLarge602-01232016-09-23
B14360201261Premium Study KitTwo Belt - XXLarge602-01232016-09-23
B143502012540SapphireSapphire 2400 Patient Unit502-0125-42016-09-23
B14350201440SapphireXPOD Interface502-01442016-09-26
B143502016910SleepViewSleepView II502-0169-12016-09-23
B14350201700SapphireLifeSense to Sapphire Serial Cable502-01702017-03-23
B143502020410ReadyRip BeltSmall - Single502-0204-12016-09-16
B143502020420ReadyRip BeltMedium - Single502-0204-22016-09-16
B143502020430ReadyRip BeltLarge - Single502-0204-32016-09-16
B143502020440ReadyRip BeltExtra Large - Single502-0204-42016-09-16
B143502020450ReadyRip BeltExtra Extra Large - Single502-0204-52016-09-16
B14350202060SleepView RIP Belt InterfaceSleepView502-02062017-03-23
B14360200451SapphireSensor Kit602-00452016-09-23

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