Twin Plus
FDA 510(k) K012976 · Grass-Telefactor Divison
510(k) numberK012976
Submission
- Device name
- Twin Plus
- Applicant
- Grass-Telefactor Divison
West-Warwick, RI, US - Received
- September 5, 2001
- Decision date
- February 12, 2002
- 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.
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|---|---|---|---|
| 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 |
Questions and answers
When was Twin Plus cleared by the FDA?
Twin Plus (K012976) received a 510(k) decision of Substantially Equivalent on February 12, 2002, 160 days after the submission was received.
What is the product code of K012976?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.