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510(k) Data Aggregation
K Number
K973267Device Name
TTM5000 TELEPHONIC EKG MONITOR
Manufacturer
Date Cleared
1998-01-29
(153 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
HDS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TTM5000 is a fully featured, non-invasive 9 Volt battery operated ECG (Electrocardiogram) Event Recorder. The intended use of TTM5000 is to record electrical heart signals (Electrocardiogram) of the patient. The recorded analog data can be transmitted over the telephone lines to a transtelephonic ECG receiving system. it is used mainly by Cardiologists and Internists to detect transient arrhythmias. The device is also called arrhythmia recorder.
Device Description
TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder.
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