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Found 3 results
510(k) Data Aggregation
K Number
K965065Device Name
TECA. MILLENNIUM
Manufacturer
MEDELEC LTD.
Date Cleared
1997-06-20
(184 days)
Product Code
GWF, GWE, GWJ, IKN, JXE
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.
Device Description
The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications.
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K Number
K964280Device Name
DG NERVUS
Manufacturer
MEDELEC LTD.
Date Cleared
1997-01-27
(91 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954157Device Name
DG PORTABLE SYSTEM
Manufacturer
MEDELEC LTD.
Date Cleared
1996-01-17
(134 days)
Product Code
OLT, GWQ, OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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