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510(k) K171506

Easyscreen by Maico Diagnostics GmbH — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2017
Date Received
May 23, 2017
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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