# K991446: Biosaca System, Model 800

- Pathway: 510(k) (Traditional)
- Applicant: Biosys AB (Publ)
- Decided: Jul 23, 1999 after 88 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
Longest line of descent: 3 generations back to K873535 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984580: Biosaca System, Biosys AB (Publ) (1999) Summary page 1.
- K971813: EMBLA, Ferguson Medical (1998) Summary page 2.

## Indications for use
The BIOSACA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The BIOSACA is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible. The BIOSACA unit is intended for use on an adult population. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

Source page: https://510kreport.com/device/K991446
Methodology: https://510kreport.com/methodology