# K071802: Tesla Guard, Model Eft G04

- Pathway: 510(k) (Traditional)
- Applicant: Mammendorfer Institut Fur Physik Und Medizin GmbH
- Decided: Nov 9, 2007 after 130 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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: 8 generations back to K946306 (1995). 34 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052119: Teslaguard, Model Eft G04, Mammendorfer Institute For Physics & Medicine GmbH (2006) Summary page 2.
- K053484: Infinity Gamma / Gammaxl, Infinity Vista, Draeger Medical Systems, Inc. (2006) Summary page 2.

## Most influential descendants
- K142032: Mri Patient Monitoring System Tesla M3 (2015), 4 descendants of its own
- K172200: 3880 MRI Patient Monitoring System (2017), 2 descendants of its own
- K180903: 3880 MRI Patient Monitoring System (2019), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own
- K153739: MRI Patient Monitor TeslaDUO (2016), 0 descendants of its own

## Indications for use
The TeslaGuard® Patient Monitor is capable of monitoring: SpO2 (Arterial Oxygen Saturation) ECG (3-Lead) IBP (Invasive Blood Pressure) NIBP (Non-invasive Blood Pressure) CO2 and Anesthetic Agents (with optional multi-gas module) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. With the optional multi-gas module installed, sampled breathing gases from adults and pediatrics can be displayed. The multi-gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture, and communicates real time and derived gas information to the TeslaGuard® Patient Monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition, The device is intended for use in the Adult, Pediatric and Neonatal populations. MRI Compatibility Statement The TeslaGuard Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.

Source page: https://510kreport.com/device/K071802
Methodology: https://510kreport.com/methodology