Cleared Traditional

LIVE VIEW PANEL (LVP)

K131415 · Neurotronics, Inc. · Neurology

Aug 2013

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K131415 is an FDA 510(k) clearance for the LIVE VIEW PANEL (LVP), 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 August 9, 2013, 85 days after receiving the submission on May 16, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K131415 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2013
Decision Date	August 09, 2013
Days to Decision	85 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.