Polysmith Sleep System, Model NTI7593
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161650 FDA 510(k)
- FDA Product Code
- OLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Polysmith Sleep System, Model NTI7593 is a standard polysomnograph with electroencephalograph. It records and amplifies physiological signals including EEG, ECG, EMG, SpO2, respiration, and ocular motility for sleep studies.
The system comprises an amplifier, head box, PC, and sensors, with software that processes data for real-time or offline review by clinicians to score polysomnograms and diagnose sleep disorders. It is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside a medical facility under direct supervision of a medical professional. The device has FDA 510(k) clearance under k-number K161650 and product code OLV, and is classified as a Class II device under regulation number 882.1400.
Frequently asked questions
What signals does the Polysmith Sleep System record?
The system records physiological signals including EEG, ECG, EMG, SpO2, respiration, and ocular motility for sleep studies.
Who is the Polysmith Sleep System intended for?
It is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside a medical facility under direct supervision of a medical professional.
What is the regulatory classification of the Polysmith Sleep System?
The device is classified as a Class II device under regulation number 882.1400.
What is the product code for the Polysmith Sleep System?
The product code for the Polysmith Sleep System is OLV.
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: Polysmith Sleep System, Model NTI7593 - Innolitics, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., Polysmith - Sleep Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161650 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurotronics, Inc.
Sources (1)
- FDA 510(k) K161650 24 fields · synced Sep 27, 2026