Cleared Traditional

SOMNOscreen plus

K201054 · Somnomedics GmbH · Neurology
Aug 2020
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K201054 is an FDA 510(k) clearance for the SOMNOscreen plus, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on August 12, 2020, 113 days after receiving the submission on April 21, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K201054 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2020
Decision Date August 12, 2020
Days to Decision 113 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.