510(k) K020955
K020955 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical, Inc. for the device "NICOLET ELECTROCAUTERY DETECTOR". The FDA issued a decision of Substantially Equivalent on April 17, 2002. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Nicolet Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2002
- Date Received
- March 25, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type