510(k) K882599
K882599 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET BRAINLAB SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 1988. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1988
- Date Received
- June 24, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conditioner, Signal, Physiological
- Device Class
- Class II
- Regulation Number
- 882.1845
- Review Panel
- NE
- Submission Type