FDA.reportPublic FDA data

Premium Study Kit

Primary DI
B14360201231
Brand
Premium Study Kit
Company
Cleveland Medical Devices Inc.
Model
Two Belt - XLarge
Catalog number
602-0123
Device description
Single use, premium study kit with two Xlarge ReadyRip Belts
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
B14360201242PackageHIBCC10In Commercial Distribution
B14360201252PackageHIBCC25In Commercial Distribution
B14360201231PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
557510625
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14350100280SleepScoutXPOD Interface501-00282016-09-26
B14350101320SleepScoutComputer Unit502-01322016-09-23
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
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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