# K993656: Datex-Ohmeda Tonometry Module M-Tono

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 15, 2000 after 138 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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 K962638 (1997). 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)
- K962638: Tonocap, TC-200 and Accessory Catheters, Instrumentarium Corp. (1997) Summary page 1.

## Most influential descendants
- K052167: Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories (2005), 0 descendants of its own

## Indications for use
The Datex-Ohmeda Tonometry Module, M-TONO is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal - arterial PCO2 difference, gastrointestinal - end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K993656
Methodology: https://510kreport.com/methodology