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510(k) K133012

SENTIERO by Path Medical GmbH — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2014
Date Received
September 25, 2013
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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