Cleared Traditional

Serenity Piezo Sensor, Serenity Thermocouple Sensor

K181709 · Neurotronics, Inc. · Neurology
Nov 2018
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K181709 is an FDA 510(k) clearance for the Serenity Piezo Sensor, Serenity Thermocouple Sensor, 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 November 16, 2018, 141 days after receiving the submission on June 28, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K181709 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2018
Decision Date November 16, 2018
Days to Decision 141 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.