510(k) K010019
K010019 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical, Inc. for the device "STERILE SUBDERMAL NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on March 19, 2001. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Nicolet Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2001
- Date Received
- January 2, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle
- Device Class
- Class II
- Regulation Number
- 882.1350
- Review Panel
- NE
- Submission Type