# K960884: Tele Trens TM 10

- Pathway: 510(k) (Traditional)
- Applicant: Life Sensing Instrument Company, Inc.
- Decided: Sep 12, 1997 after 557 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120052: Cvinsight (2012), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K960884
Methodology: https://510kreport.com/methodology