510(k) K103140
K103140 is an FDA 510(k) premarket notification submitted by Carefusion 209, Inc. for the device "NICOLET WIRELESS EEG". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Carefusion 209, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2011
- Date Received
- October 25, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type