510(k) K053606
K053606 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "BE PLUS / AURA-LTM64 AMPLIFIER". The FDA issued a decision of Substantially Equivalent on January 24, 2006. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2006
- Date Received
- December 27, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type