510(k) K201054
K201054 is an FDA 510(k) premarket notification submitted by Somnomedics GmbH for the device "SOMNOscreen plus". The FDA issued a decision of Substantially Equivalent on August 12, 2020. The device falls under product code OLV (Standard Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Somnomedics GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2020
- Date Received
- April 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Standard Polysomnograph With Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
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.