Cleared Traditional

Falcon HST

K242447 · Compumedics Limited · Neurology
Feb 2025
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K242447 is an FDA 510(k) clearance for the Falcon HST, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on February 20, 2025, 188 days after receiving the submission on August 16, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K242447 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date February 20, 2025
Days to Decision 188 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.