# K993608: Datex-Ohmeda NE12STPR Module (Model Family M-NE12STPR)

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Apr 13, 2000 after 171 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031781: Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and Accessories (2003), 0 descendants of its own

## Indications for use
The Datex-Ohmeda NE12STPR module (model family M-NE12STPR) and accessories are 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 and invasive blood pressure. Impedance Respiration measurement is indicated for patient’s ages 3 and up. The NIBP measurement is indicated for patients with weight from 5kg (111b.) up. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K993608
Methodology: https://510kreport.com/methodology