OMNI 2000 SERIES ITC HEARING AID

Hearing Aid, Air Conduction

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Omni 2000 Series Itc Hearing Aid.

Pre-market Notification Details

Device IDK934417
510k NumberK934417
Device Name:OMNI 2000 SERIES ITC HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie,  MN  55344
ContactJerrold Lang
CorrespondentJerrold Lang
STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-13
Decision Date1993-11-29

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