# K962103: Bio-Logic Sleepscan Product with Built-in Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Aug 22, 1996 after 84 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 K930790 (1994). 2 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930790: Addition of Built-in Oxymeter to Sleepscan Prod., Bio-Logic Systems Corp. (1994) Summary page 1.
- K954954: Ceegraph Traveler Ambulatory Eeg Recorder, Bio-Logic Systems Corp. (1996) Summary page 1.

## Most influential descendants
- K012437: Devilbiss Sleep Recorder Model # RM60 (2002), 42 descendants of its own
- K040595: ALICE 5 (2004), 40 descendants of its own
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K130007: Sleep Profiler (2013), 14 descendants of its own

## Indications for use
The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG signals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and leg movement, body position while sleeping, pulse rate, and level of oxygen in the blood. Analysis features of the Sleepscan product allow for manipulation and presentation of this data in ways which enhance the physician's ability to reach informed diagnostic decisions quickly and efficiently. Although the addition of an internal oximeter does not, in itself, add to the features or capabilities of the Sleepscan product, it provides a simplification in hardware design which results in faster patient setup with fewer potential errors in setup. This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product. Sleepscan with Built-In Oximeter can be used for patients of all ages, although most Sleep disorders occur in adults. The equipment does not provide alarms and cannot be used as an automated apnea monitor.

Source page: https://510kreport.com/device/K962103
Methodology: https://510kreport.com/methodology