510(k) K803226

EVOKED RESPONSE STIMULATORS by Bio-Logic Systems Corp. — Product Code GWK

K803226 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "EVOKED RESPONSE STIMULATORS". The FDA issued a decision of Substantially Equivalent on February 5, 1981. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Bio-Logic Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1981
Date Received
December 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type