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K Number
K992425
Device Name
TES-20
Manufacturer
TES ELECTRICAL ELECTRONIC CORP.
Date Cleared
1999-10-19

(90 days)

Product Code
MWJ
Regulation Number
870.2800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking about. The document is an FDA letter acknowledging the substantial equivalence of the TES-20 Holter ECG Recorder to a legally marketed predicate device, allowing it to be marketed. It does not include information on specific performance metrics, test methodologies, or clinical study results.

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).