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510(k) Data Aggregation
K Number
K960741Device Name
COMFORTONE PHS
Manufacturer
Date Cleared
1996-05-07
(74 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
COMFORTONE AMERICA'S VALUE HEARING AID LINE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To amplifiy and transmit sound to the ear.
Device Description
In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids. Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
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