# K982405: MTEK-1000

- Pathway: 510(k) (Traditional)
- Applicant: Magna Advanced Technologies, Inc.
- Decided: Sep 17, 1998 after 69 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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 MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity, Federal Law restricts the use of this device by or on the order of a qualified physician only.

Source page: https://510kreport.com/device/K982405
Methodology: https://510kreport.com/methodology