510(k) K112353
K112353 is an FDA 510(k) premarket notification submitted by Electrical Geodesics, Inc. for the device "GEODESIC EEG MOBILE 100 (GEM 100)". The FDA issued a decision of Substantially Equivalent on February 17, 2012. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Electrical Geodesics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2012
- Date Received
- August 16, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full-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 full montage array (i.e., 16 or more electrodes) and user-specified locations