Cleared Traditional

Serenity Body Position Sensor, Serenity RIP Sensors

K173868 · Neurotronics, Inc. · Neurology
Jul 2018
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K173868 is an FDA 510(k) clearance for the Serenity Body Position Sensor, Serenity RIP Sensors, 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 July 2, 2018, 194 days after receiving the submission on December 20, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K173868 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2017
Decision Date July 02, 2018
Days to Decision 194 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.