510(k) K895443

MODEL 210 IMPEDANCE SYSTEM by Virtual Corp. — Product Code ETY

K895443 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 210 IMPEDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1990. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Virtual Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1990
Date Received
September 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type