510(k) K982441

CCA-220 by Benson Medical Instruments Co. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1998
Date Received
July 14, 1998
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