510(k) K871480

STD-228 SPECTRAL TREND DISPLAY by Grass-Telefactor Product Group — Product Code GWS

K871480 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "STD-228 SPECTRAL TREND DISPLAY". The FDA issued a decision of Substantially Equivalent on May 1, 1987. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Grass-Telefactor Product Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1987
Date Received
April 14, 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