# K043354: Modular Telemetry System for the Vision Telepak, Model 20701

- Pathway: 510(k) (Special)
- Applicant: Invivo Research, Inc.
- Decided: Jan 10, 2005 after 35 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970763 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970763: Modular Telemetry System (MTS) Option for the Mde Escort II Monitor, Medical Data Electronics (1997) Summary page 1.

## Indications for use
The Vision Telepakt M Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

Source page: https://510kreport.com/device/K043354
Methodology: https://510kreport.com/methodology