Cleared Special

Grass TWin

K173690 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology

Mar 2018

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K173690 is an FDA 510(k) clearance for the Grass TWin, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on March 9, 2018, 98 days after receiving the submission on December 1, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K173690 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2017
Decision Date	March 09, 2018
Days to Decision	98 days
Submission Type	Special
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.