510(k) K871931
K871931 is an FDA 510(k) premarket notification submitted by Neuroscience, Inc. for the device "ISTAT SOFTWARE". The FDA issued a decision of Substantially Equivalent on October 13, 1987. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Neuroscience, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1987
- Date Received
- May 19, 1987
- 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