510(k) K062533
K062533 is an FDA 510(k) premarket notification submitted by Neurovirtual USA, Inc. for the device "BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Neurovirtual USA, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- August 29, 2006
- 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.