510(k) K930553

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT by Etymotic Research — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1993
Date Received
February 3, 1993
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