510(k) K092625
K092625 is an FDA 510(k) premarket notification submitted by Wavestate, Inc. for the device "WAVESTATE NEUROMONITOR". The FDA issued a decision of Substantially Equivalent on June 29, 2010. The device falls under product code ORT (Burst Suppression Detection Software For Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2010
- Date Received
- August 27, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Burst Suppression Detection Software For Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.