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510(k) Data Aggregation
K Number
K960884Device Name
TELE TRENS TM 10
Manufacturer
Date Cleared
1997-09-12
(557 days)
Product Code
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
LIFE SENSING INSTRUMENT COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TeleTrens is intended for use in the non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration in the hospital/clinic environment.
The TeleTrens is intended to be used in accordance with accepted hospital and clinical protocols and instructions contained in this operators manual. Use of the TeleTrens for applications not specified in this manual may result in inaccurate patient information. Use of the TeleTrens with other than recommended or supplied accessories or parts may result in inaccurate patient information or damage to the monitor.
Federal law restricts this device to sale by or on the order of a physician.
Device Description
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