# K963631: Sleep Study Analysis (Ssa) Version 96.10

- Pathway: 510(k) (Traditional)
- Applicant: Omega Results
- Decided: Apr 2, 1997 after 203 days
- Product code: OLZ (Automatic Event Detection Software For 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
This product is indicated for use under the supervision of a Physician. This product is indicated for use in the computer aided scoring of sleep study recordings. PATIENT POPULATION SSA is intended for use in the adult population with suspected disorders of sleep. PHYSIOLOGICAL PARAMETERS SSA is intended for use in providing computer assisted human review of the following physiological parameters for the purpose of staging and identifying events in sleep: Electroencephalogram Electromyogram Electrocardiogram Respiratory Effort Respiratory Air Flow Pulse Oximetry CLINICAL UTILITY OF SUMMARY REPORT OUTPUT The clinical utility of SSA summary report output is to assist a trained clinician in the review of polysomnographic recordings so that the clinician may more easily identify sleep stage events. SSA is indicated for use only when operated by a trained clinician who reviews and determines the presence of sleep stage events. SSA is in no way intended to replace a human clinician in discriminating the existence and type of any sleep event which may have occurred. ENVIRONMENT OF USE: SSA is indicated for use in a hospital sleep laboratory or a free standing sleep laboratory.

Source page: https://510kreport.com/device/K963631
Methodology: https://510kreport.com/methodology