# K981378: Datex-Engstrom Light Monitor Models F-LM1, F-LMP1

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: Nov 3, 1998 after 201 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient’s ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case. The monitor is intended for use by qualified medical personnel only. The Light Monitor is intended for patients with weight of 5kg (111b.) or more. Respiration monitoring is intended for patients ages 3 and up.

Source page: https://510kreport.com/device/K981378
Methodology: https://510kreport.com/methodology