# K071899: Bis Module for Envoy Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Oct 22, 2007 after 105 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K060900 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060900: Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842, Spacelabs Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K083063: Bis Interface for Vitalogik Patient Monitors (2008), 0 descendants of its own

## Indications for use
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vita) signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Neninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO,. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population. The Intended Use of the Envoy monitor as indicated above is same as the Indications For Use.

Source page: https://510kreport.com/device/K071899
Methodology: https://510kreport.com/methodology