# K111742: Mdrive

- Pathway: 510(k) (Special)
- Applicant: Embla Systems
- Decided: Aug 31, 2011 after 71 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992283 (1999). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024322: Embla N7000, Medcare Flaga (2003) Summary page 1.

## Most influential descendants
- K180290: Natus Brain Monitor Amplifier (2018), 1 descendant of its own
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own

## Indications for use
The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

Source page: https://510kreport.com/device/K111742
Methodology: https://510kreport.com/methodology