510(k) K072964
K072964 is an FDA 510(k) premarket notification submitted by Cardinal Health, Inc. for the device "NICOLET CORTICAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on December 30, 2008. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Cardinal Health, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2008
- Date Received
- October 19, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type