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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?
Product Code :
LRB
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
K961593Device Name
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
Manufacturer
Date Cleared
1996-11-07
(197 days)
Product Code
Regulation Number
874.3300Why did this record match?
Product Code :
LRB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.
Device Description
Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2.
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