# K992283: Artisan Acquisition System for Eeg and Polysomnography

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Aug 27, 1999 after 51 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
114 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K024322: Embla N7000 (2003), 113 descendants of its own
- 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

## Indications for use
The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.

Source page: https://510kreport.com/device/K992283
Methodology: https://510kreport.com/methodology