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510(k) K081841

AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER by Amplivox, Ltd. — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2008
Date Received
June 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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