Aura-Psg
FDA 510(k) K050425 · Astro-Med, Inc.
510(k) numberK050425
Submission
- Device name
- Aura-Psg
- Applicant
- Astro-Med, Inc.
West Warwick, RI, US - Received
- February 18, 2005
- Decision date
- October 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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.
Other 510(k)s with product code OLV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261747 | Report StudioOLV · Traditional | Beacon Biosignals, Inc. | 08/25/2026SE |
| K260585 | Noxturnal WebOLV · Special | Nox Medical Ehf | 03/20/2026SE |
| K242447 | Falcon HSTOLV · Traditional | Compumedics Limited | 02/20/2025SE |
| K241288 | Noxturnal WebOLV · Traditional | Nox Medical Ehf | 12/23/2024SE |
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | Somnomedics GmbH | 12/08/2024SE |
| K213007 | Cerebra Sleep SystemOLV · Traditional | Cerebra Medical , Ltd. | 07/06/2022SE |
| K201054 | SOMNOscreen plusOLV · Traditional | Somnomedics GmbH | 08/12/2020SE |
| K192624 | ApneaTrakOLV · Traditional | Cadwell Industries, Inc. | 02/20/2020SE |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional | Neurotronics, Inc. | 11/16/2018SE |
| K173868 | Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional | Neurotronics, Inc. | 07/02/2018SE |
More from Neurotronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081551 | Twin Neurotrac-IiiOMA · Traditional | 12/24/2008SE |
| K033978 | AdamGWQ · Traditional | 02/18/2004SE |
| K970951 | Grass Brainwave SoftwareOLV · Traditional | 05/19/1997SE |
| K963669 | Grass Model 15 Neurodata Amplifier SystemGWL · Traditional | 12/12/1996SE |
| K934644 | K3 SystemDRT · Traditional | 11/01/1994SE |
| K912929 | Dash IVDSF · Traditional | 08/13/1991SE |
| K896164 | ASC-954 Integrator AmplifierGWK · Traditional | 01/22/1990SE |
| K894295 | Astro-Med ASC-951 Pressure ProcessorDRQ · Traditional | 01/18/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | 12/13/1989SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | 09/18/1989SE |
Questions and answers
When was Aura-Psg cleared by the FDA?
Aura-Psg (K050425) received a 510(k) decision of Substantially Equivalent on October 20, 2005, 244 days after the submission was received.
What is the product code of K050425?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.