HEARING AID (MODEL 695D, 905 & 960P)

Hearing Aid, Air Conduction

UNITRON INDUSTRIES, INC.

The following data is part of a premarket notification filed by Unitron Industries, Inc. with the FDA for Hearing Aid (model 695d, 905 & 960p).

Pre-market Notification Details

Device IDK760996
510k NumberK760996
Device Name:HEARING AID (MODEL 695D, 905 & 960P)
ClassificationHearing Aid, Air Conduction
Applicant UNITRON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-11-08
Decision Date1976-11-16

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