# K051217: Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin, E=Pretin, E-PP and E-PT/E-P)

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Feb 3, 2006 after 267 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 K041772 (2004). 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)
- K041772: Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and Accessories, Datex-Ohmeda (2004) Summary page 2.

## Most influential descendants
- K062324: Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN (2006), 0 descendants of its own

## Indications for use
The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT, and E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patients ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051217
Methodology: https://510kreport.com/methodology