510(k) K912938
K912938 is an FDA 510(k) premarket notification submitted by Stellate Systems for the device "RHYTHM". The FDA issued a decision of Substantially Equivalent on July 30, 1991. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Stellate Systems has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1991
- Date Received
- July 5, 1991
- 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