PRIMUS HEARING INSTRUMENT TEST UNIT— 510(k) K113831

Substantially Equivalent

Auditdata A/S

FDA 510(k) clearance K113831 for PRIMUS HEARING INSTRUMENT TEST UNIT, Substantially Equivalent on 2012-04-19. Applicant: Auditdata A/S.

Clearance details

Applicant: Auditdata A/S
Product code: Code ETW
Advisory panel: Ear, Nose, Throat
Date received: 2011-12-27
Decision date: 2012-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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