# K070326: Noga Automated Sleep Study Scoring and Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Widemed, Ltd.
- Decided: May 5, 2007 after 89 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: 4 generations back to K910870 (1991). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022506: Morpheus 1, Automated Sleep Study Scoring & Data Management System, Widemed, Ltd. (2003) Summary page 1.
- K000253: Silent Night V, Sleep Solutions, Inc. (2000) Summary page 1.
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 1.

## Most influential descendants
- K111314: Morpheus OX (2011), 0 descendants of its own
- K073269: HC1000P Sleep Diagnosis Software System (2008), 0 descendants of its own

## Indications for use
The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders. The Noga System is intended to be used for analysis, display, redisplay (tettieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device. Physiological data includes: ECO, SpO2, EtCO 2 and Impedance respiration.

Source page: https://510kreport.com/device/K070326
Methodology: https://510kreport.com/methodology