# K024322: Embla N7000

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Flaga
- Decided: Oct 27, 2003 after 305 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: 1 generation back to K992283 (1999). 1 ancestor in all.
113 later devices descend from it; 5 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992283: Artisan Acquisition System for Eeg and Polysomnography, Airsep Corp. (1999) Summary page 1.

## Most influential descendants
- K041904: Compass F10 System (2004), 54 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K041724: Compass M10 System (2004), 41 descendants of its own
- K061405: Apnealink, Model 22302 (2006), 30 descendants of its own
- K070263: Apnealink (2007), 29 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/K024322
Methodology: https://510kreport.com/methodology