What is FDA product code OLV?

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.

Neurology › DiagnosticStandard Polysomnograph With Electroencephalograph

Compumedics Falcon

Name: Compumedics Falcon
Brand: Compumedics Falcon

Falcon HST records physiological signals to help qualified healthcare practitioners diagnose sleep disorders in adults. It is intended for use at home or in a clinical environment under…

Registry build 21.09.26

Falcon HST records physiological signals to help qualified healthcare practitioners diagnose sleep disorders in adults. It is intended for use at home or in a clinical environment under professional direction. The recorder captures EEG and respiratory signals alongside other study data.

The main unit is worn on the chest over clothing and has a touchscreen with inputs for electrodes and respiratory bands. Sensors record nasal airflow, breathing effort, oxygen saturation, pulse and body position. A charging cradle also provides a USB connection for transferring study data to a computer.

Listed Item

Falcon HST System

Study Review

Compatible Profusion Sleep software supports data retrieval, review and analysis. The recorder supplies physiological information for clinical interpretation during a sleep study.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OLV
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13

Record

Regulatory record for Compumedics Falcon
Listed by	Compumedics Limited, Australia
FDA product code	OLV
Device type	Standard Polysomnograph With Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Complaint-file establishment, Manufacturer, Exporter
510(k)	K242447
Record published	2026-03-12

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Compumedics Falcon
Catalogue number	Size	Status
Falcon HST		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Alice 6	Respironics Inc.	58
Somnostar	Carefusion	28
Standard Polysomnograph With Electroencephalograph	Nihon Kohden America, Inc.	18
Standard Polysomnograph With Electroencephalograph	Nihon Kohden Corp.	17
Sleep Profiler PSG2	Advanced Brain Monitoring, Inc.	10
Sleep Profiler	Advanced Brain Monitoring, Inc.	8
Trackit Sleepwalker	Lifelines Ltd.	8
micromed	Micromed, Inc.	7
Compumedics Grael	Compumedics Limited	6
Neurovirtual	Neurovirtual USA, Inc.	4
Pro-Flow	Respironics Inc.	3
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m	Neurotronics, LLC	3

Showing 12 of 89. All products under Standard Polysomnograph With Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242447	2025-02-20
K003175	2000-12-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.