AUDIOTONE ITE HEARING AID MODEL ZD (XT)

Hearing Aid, Air Conduction

MIRACLE-EAR, INC.

The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Audiotone Ite Hearing Aid Model Zd (xt).

Pre-market Notification Details

Device IDK901746
510k NumberK901746
Device Name:AUDIOTONE ITE HEARING AID MODEL ZD (XT)
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis,  MN  55426
ContactKevin Kutina
CorrespondentKevin Kutina
MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis,  MN  55426
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-17
Decision Date1990-05-29

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