Nomad Sleep System Recorder, Model PMU800
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092699 FDA 510(k)
- FDA Product Code
- GWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1835 FDA 510(k)
- Regulation Number
- 882.1835 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nomad Sleep System Recorder, Model PMU800 is a physiological signal amplifier intended for use in polysomnography or sleep studies. It captures bio-potential signals including limb movement, body position, respiration effort, and SpO2, and transfers raw physiological data to Polysmith software on a personal computer.
The device is restricted to sale by or on the order of a physician under U.S. federal law. It is supplied as a reusable recorder system and requires connection to external sensors and software for operation. No information regarding sterility, MRI safety, storage conditions, or specific sizes is provided in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699) — FDA 510(k ..., NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 510(k)… - FDA.report, Nihon Kohden Neurotronics Nomad PMU800 Portable Recorder ... - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092699 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurotronics, Inc.
Sources (1)
- FDA 510(k) K092699 24 fields · synced Sep 22, 2026