FDA.reportPublic FDA data

TMSi

Primary DI
08719481170028
Brand
TMSi
Company
TMSi
Model
8
Device description
Physiologic data acquisition device
Published
2017-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K060374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060374000REFA, PHYSIOLOGICAL AMPLIFIERTms International BV2006-05-30GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719481170028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719481170028087194811700288719481170028

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.

Contacts#

Phone, Email table
PhoneEmail
+31541534603support@tmsi.com

Regulatory Flags#

DUNS number
412590226
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719481170011TMSi72017-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009903715Quick-20mCGX, LLCGWL2025-09-29
B195EE223eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
B195EE225eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
00817111021332PolysmithNeurotronics, LLCGWL2025-09-23
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWL2025-05-19
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
08056446900673Neurotravel LIGHTEB NEURO SPAGWL2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWL2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWL2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWL2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWL2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWL2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWL2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWL2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWL2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWL2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWL2024-12-04
EBCI5730PRO0g.Nautilus PROg.tec medical engineering GmbHGWL2024-05-28
00814901021527Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2023-12-04