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510(k) K113831

PRIMUS HEARING INSTRUMENT TEST UNIT by Auditdata A/S — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2012
Date Received
December 27, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

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  • K980377 — FONIX FP35 HEARING AID ANALYZER (March 18, 1998)