510(k) K926574

MODEL 330 SCREENING AUDIO METER, MODIFIED by Virtual Corp. — Product Code GWJ

K926574 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 330 SCREENING AUDIO METER, MODIFIED". The FDA issued a decision of Substantially Equivalent on March 29, 1993. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Virtual Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1993
Date Received
December 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type