g.HIamp

Primary DI
EBCI7001US0
Brand
g.HIamp
Company
g.tec medical engineering GmbH
Model
80-Channel Amplifier
Catalog number
7001
Device description
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
Published
2017-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K123255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123255000g.HIampG.Tec Medical Engineering GmbH2012-12-20GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBCI70010PreviousHIBCC0
EBCI7001US0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity25 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+437251222400support@gtec.at

Regulatory Flags#

DUNS number
300916041
Device count
1
Serial number
true

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