# K093766: Vitalogik 6000/6500

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Ltd.
- Decided: May 7, 2010 after 151 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. The FDA summary names no predicate by number.

## Most influential descendants
- K141441: Menntor X7 (2015), 0 descendants of its own

## Indications for use
VitaLogik 6000/6500 is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik 6000/6500 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik 6000/6500 is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: * Critical Care Patients * Cardiac Step-down/Telemetry Units * Emergency Departments * Intra.-operative (Anesthesia) Monitoring * Post Anesthesia Care

Source page: https://510kreport.com/device/K093766
Methodology: https://510kreport.com/methodology