Cleared Traditional

Polysmith Sleep System, Model NTI7593

K161650 · Neurotronics, Inc. · Neurology

Jan 2017

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K161650 is an FDA 510(k) clearance for the Polysmith Sleep System, Model NTI7593, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 19, 2017, 218 days after receiving the submission on June 15, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K161650 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2016
Decision Date	January 19, 2017
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLV — Standard Polysomnograph With Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.