510(k) K021144
K021144 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical, Inc. for the device "SUBDURAL STRIP ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 24, 2002. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Nicolet Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2002
- Date Received
- April 9, 2002
- 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