510(k) K180290
K180290 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) for the device "Natus Brain Monitor Amplifier". The FDA issued a decision of Substantially Equivalent on June 14, 2018. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2018
- Date Received
- February 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full-Montage Standard Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations