Devices · Compumedics Limited

Falcon HST

Compumedics Limited is listed for Falcon HST (K242447). The FDA list gives February 20, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OLV as “Standard Polysomnograph With Electroencephalograph”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242447

Official FDA database record

Date of final decision

February 20, 2025

Company on the FDA list

Compumedics Limited

Lead panel

Neurology

Primary product code

OLV

openFDA device name for the code

Standard Polysomnograph With Electroencephalograph

Device class

2

Regulation number

882.1400

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary