510(k) K831896

COMPACT FOUR by Nicolet Biomedical Instruments — Product Code GWF

K831896 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "COMPACT FOUR". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type