510(k) K033010
K033010 is an FDA 510(k) premarket notification submitted by Brainz Instruments , Ltd. for the device "BRM2 BRAIN MONITOR". The FDA issued a decision of Substantially Equivalent on October 10, 2003. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Brainz Instruments , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2003
- Date Received
- September 26, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.