MODEL SE-1 EYEGLASS 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 Model Se-1 Eyeglass Hearing Aid.

Pre-market Notification Details

Device IDK791203
510k NumberK791203
Device Name:MODEL SE-1 EYEGLASS HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-28
Decision Date1979-08-10

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