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Found 9 results
510(k) Data Aggregation
K Number
K982723Device Name
MAICO MA42
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1998-10-28
(84 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indication for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
Device Description
Not Found
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K Number
K981142Device Name
MAICO MA53
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1998-04-22
(23 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
Device Description
Not Found
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K Number
K974069Device Name
OPUS 2 - CANAL SERIES (ITC)
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-12-15
(48 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.
Device Description
OPUS 2 - CANAL SERIES ( ITC )
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K Number
K974152Device Name
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-12-15
(41 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: X 1. Slight X 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low Tolerance To Loudness 2. 3.
Device Description
OPUS 2 - COMPLETELY - IN - CANAL SERIES ( CIC ) Device Name:
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K Number
K974211Device Name
OPUS 2 - FULL CONCHA SERIES - ITE
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-12-15
(35 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A. General Indications:
The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories:
| Severity: | Configuration: | Other: |
|-----------------|--------------------------------------------------|-----------------------------------|
| ___ 1. Slight | ___ 1. High Frequency<br>- Precipitously Sloping | X 1. Low Tolerance<br>To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. ___ |
| X 3. Moderate | ___ 3. Reverse Slope | 3. ___ |
| X 4. Severe | X 4. Flat | |
| ___ 5. Profound | ___ 5. Other | |
Device Description
Not Found
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K Number
K973948Device Name
DUALINE 100 BTE
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-10-28
(12 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.
Device Description
DUALINE 100 BTE
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K Number
K971158Device Name
DUALINE 400 CIC
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-06-13
(77 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight, X 2. Mild, X 3. Moderate, 4. Severe, 5. Profound. Configuration: X 1. High Frequency - Precipitously Sloping, X 2. Gradually Sloping, X 3. Reverse Slope, X 4. Flat, 5. Other. Other: X 1. Low Tolerance To Loudness, 2., 3.
Device Description
DUALINE 400 CIC
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K Number
K971080Device Name
MAICO MA52
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-06-06
(73 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
Device Description
Not Found
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K Number
K962275Device Name
MAICO MA25 SERIES II WITH SPEECH
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1996-09-05
(84 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
BERNAFON-MAICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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