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510(k) K011114

ETYMOTIC RESEARCH ER-10D OAE PROBE by Etymotic Research — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2001
Date Received
April 12, 2001
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

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