Cleared Traditional

Cerebra Sleep System

K213007 · Cerebra Medical , Ltd. · Neurology
Jul 2022
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K213007 is an FDA 510(k) clearance for the Cerebra Sleep System, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Cerebra Medical , Ltd. (Winnipeg, CA). The FDA issued a Cleared decision on July 6, 2022, 289 days after receiving the submission on September 20, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K213007 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2021
Decision Date July 06, 2022
Days to Decision 289 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.