510(k) K981439

CCA-200 by Benson Medical Instruments Co. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1998
Date Received
April 21, 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