# K013450: Notta Ambulatory Recorder

- Pathway: 510(k) (Abbreviated)
- Applicant: Stellate Systems
- Decided: Jan 14, 2002 after 89 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.
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 Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician’s order. The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health carc professional. The device is intended to be wom by the patient during a recording session. The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital signs, in critical care or intra-operative settings. In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K013450
Methodology: https://510kreport.com/methodology