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510(k) Data Aggregation
K Number
K974219Device Name
FACEPLATE ASSEMBLY
Manufacturer
Date Cleared
1998-02-20
(102 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
FINETONE HEARING INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Device Description
Finetone ITE Faceplate Assembly, Model M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls.
Finetone ITE Faceplate Assembly, Model M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls.
Finetone ITE Faceplate Assembly, Model M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls.
Finetone ITE Faceplate Assembly, Model M-KAMP detects and amplifies quiet sounds. In loud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls.
Finetone ITE Faceplate Assembly, Model M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls.
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K Number
K955692Device Name
FINETONE FSC,
Manufacturer
Date Cleared
1996-02-02
(50 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
FINETONE HEARING INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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