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510(k) Data Aggregation
K Number
K992425Device Name
TES-20
Manufacturer
TES ELECTRICAL ELECTRONIC CORP.
Date Cleared
1999-10-19
(90 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
TES ELECTRICAL ELECTRONIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.
Device Description
Tes Electrical Electronic Corp. TES-20 Holter ECG Recorder
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