510(k) K894629
K894629 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET BEAM II SYSTEM". The FDA issued a decision of Substantially Equivalent on March 9, 1990. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1990
- Date Received
- July 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Spectrum, Electroencephalogram Signal
- Device Class
- Class I
- Regulation Number
- 882.1420
- Review Panel
- NE
- Submission Type