# K060135: Mortara Surveyor Telemetry Central Station

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: May 15, 2006 after 116 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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
Longest line of descent: 1 generation back to K922927 (1992). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922927: Mortara Instrument ST Central Station, Mortara Instrument, Inc. (1992) Summary page 1.
- K000882: Datex-Ohmeda CS/3 Telemetry System, Datex-Ohmeda (2000) Summary page 1.

## Most influential descendants
- K131929: Surveyor Central Station (2013), 6 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K123556: Mortara Surveyor Patient Monitor (2013), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own

## Indications for use
The Surveyor Central Telemetry System Is indicated for use: * in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. * centralized ECG monitoring through a telemetry network of adult patients in Coronary Care Units, Step-Down Units, Emergency Departments. It is not designed for use in highly invasive environments, such as an operating theatre. * Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile. * Chest Pain Evaluation. * Evaluation of adult patients with pacemakers. * Evaluation of a patient's response after resuming occupational or recreational activities (e.g.. after M.I. or cardiac surgery.) * Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. * Clinical and epidemiological research studies.

Source page: https://510kreport.com/device/K060135
Methodology: https://510kreport.com/methodology