510(k) K854662
K854662 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "OEE_7102 EEG/TREND MONITOR". The FDA issued a decision of Substantially Equivalent on August 20, 1986. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1986
- Date Received
- November 20, 1985
- 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