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510(k) K994254

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER by International Distributors of Electronics For Medi — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2000
Date Received
December 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

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