510(k) K081151
K081151 is an FDA 510(k) premarket notification submitted by Compumedics USA, Ltd. for the device "COMPUMEDICS NEUVO". The FDA issued a decision of Substantially Equivalent on September 8, 2008. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Compumedics USA, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2008
- Date Received
- April 23, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
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