PA EQUALIZER

Hearing Aid, Air Conduction

ELECTONE, INC.

The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Pa Equalizer.

Pre-market Notification Details

Device IDK863787
510k NumberK863787
Device Name:PA EQUALIZER
ClassificationHearing Aid, Air Conduction
Applicant ELECTONE, INC. P.O. BOX 910 Winter Park,  FL  32790
ContactMichael D Underhill
CorrespondentMichael D Underhill
ELECTONE, INC. P.O. BOX 910 Winter Park,  FL  32790
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-26
Decision Date1986-10-14

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