Polysmith Sleep System, Model NTI7593
510(k) K161650
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161650 | Date19 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K161650
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLV
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
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.
Similar devices
Other devices filed under FDA product code OLV (Standard Polysomnograph With Electroencephalograph).
- AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 by NIHON KOHDEN AMERICA, INC.
- Micromed SD LTM 64 PLUS by Micromed, Inc.
- Noxturnal Web by Nox Medical
- NEUROFAX, MODELS EEG-1100A, EEG-9100A by NIHON KOHDEN AMERICA, INC.
- SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM by Grass-Telefactor Product Group
- EMBLA by Ferguson Medical
- micromed BRAIN QUICK by Micromed, Inc.
- MEDIPALM-20 by Braebon Medical Corp.
- ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. by Oxford Medilog, Inc.
- GALAXY SYSTEM; JUPITER by Personal Health Institute International
Other devices from Neurotronics, LLC
Questions
AI-generated answers, 27 Sep 2026
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.