510(k) K915820
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1995
- Date Received
- December 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Normalizing Quantitative Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.