510(k) K101386
K101386 is an FDA 510(k) premarket notification submitted by Infinite Biomedical Technologies, LLC for the device "VIGILANT EEG MONITOR MODEL VIGILANT 2.0". The FDA issued a decision of Substantially Equivalent on July 30, 2010. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Infinite Biomedical Technologies, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2010
- Date Received
- May 18, 2010
- Clearance Type
- Special
- 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