510(k) K863984

MODEL 320 TWO CHANNEL AUDIOMETER by Virtual Corp. — Product Code EWO

K863984 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 320 TWO CHANNEL AUDIOMETER". The FDA issued a decision of Substantially Equivalent on November 18, 1986. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Virtual Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type