510(k) K120979
K120979 is an FDA 510(k) premarket notification submitted by Carefusion 209, Inc. for the device "CAREFUSION NICOLET EDX". The FDA issued a decision of Substantially Equivalent on April 25, 2012. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Carefusion 209, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2012
- Date Received
- April 2, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type