510(k) K974718
K974718 is an FDA 510(k) premarket notification submitted by Persyst Development Corp. for the device "PERSYST PRISM". The FDA issued a decision of Substantially Equivalent on March 9, 1998. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Persyst Development Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1998
- Date Received
- December 17, 1997
- 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