FDA.reportPublic FDA data

Narcotrend-Compact M

Primary DI
04260497021063
Brand
Narcotrend-Compact M
Company
MT MonitorTechnik GmbH & Co. KG
Model
T5
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLWIndex-Generating Electroencephalograph Software
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLWIndex-Generating Electroencephalograph SoftwareNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033543000NARCOTREND, MODEL COMPACT 4.0Mt Monitortechnik GmbH & Co. KG2004-09-17OLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260497021070PackageGS12In Commercial Distribution
04260497021063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260497021070042604970210704260497021070
04260497021063042604970210634260497021063

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494192201753info@monitortechnik.de

Regulatory Flags#

DUNS number
388136913
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260497025009Narcotrend Patient leadPKM12018-05-09
04260497025016Narcotrend Patient leadPKM42018-05-09
04260497026006Narcotrend ElectrodeEE-02032018-05-15

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Primary DI, Brand, Company table
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