# K092699: Nomad Sleep System Recorder, Model PMU800

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Mar 18, 2010 after 197 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neurotronics Sphinx: named in the summary without a submission number

## Most influential descendants
- K220631: NomadAir PMU810 (2022), 1 descendant of its own
- K240646: DreamClear (2024), 0 descendants of its own
- K223676: SomniCheck (2023), 0 descendants of its own

## Indications for use
The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram. The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. This device is not to be used alone as an apnea monitor or as a critical component in an apnea monitoring system. This device is intended for use on both adults and children on the order of physician. This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. The device is not sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K092699
Methodology: https://510kreport.com/methodology