SOMNOscreen plus
FDA 510(k) K201054 · Somnomedics GmbH
510(k) numberK201054
Submission
- Device name
- SOMNOscreen plus
- Applicant
- Somnomedics GmbH
Randersacker, DE - Received
- April 21, 2020
- Decision date
- August 12, 2020
- 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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More from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
| 510(k) | Device | Decision |
|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | 12/08/2024SE |
| K231104 | ABPMproDSH · Traditional | 11/27/2023SE |
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| K140861 | Somnotouch RespMNR · Traditional | 01/30/2015SE |
| K081485 | SomnowatchMNR · Traditional | 09/18/2008SE |
| K071556 | Somnoscreen EEG10-20MNR · Special | 07/18/2007SE |
| K060708 | SomnoscreenMNR · Traditional | 01/24/2007SE |
Questions and answers
When was SOMNOscreen plus cleared by the FDA?
SOMNOscreen plus (K201054) received a 510(k) decision of Substantially Equivalent on August 12, 2020, 113 days after the submission was received.
What is the product code of K201054?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.