510(k) K130013
K130013 is an FDA 510(k) premarket notification submitted by Advanced Brain Monitoring, Inc. for the device "X4 SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 2013. The device falls under product code OMC (Reduced- Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Advanced Brain Monitoring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2013
- Date Received
- January 2, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reduced- 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 user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes