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510(k) Data Aggregation
K Number
K973377Device Name
SIBELMED AC50D
Manufacturer
Date Cleared
1998-03-10
(183 days)
Product Code
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
TRUTONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
Device Description
It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.
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K Number
K972550Device Name
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
Manufacturer
Date Cleared
1997-07-31
(31 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
TRUTONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K972552Device Name
AUDIFON H20 PC/AUDIFON H32 PP
Manufacturer
Date Cleared
1997-07-30
(30 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
TRUTONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other Other 1. Low tolerance To Loudness 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. 2. 3.
Device Description
Not Found
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K Number
K972542Device Name
JAZZ PP AGC-O, JAZZ PP
Manufacturer
Date Cleared
1997-07-23
(14 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
TRUTONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity: Severe
Configuration: Flat
Other: Low tolerance To Loudness; JAZZ PP AGC-C
Device Description
Not Found
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K Number
K972543Device Name
TWIST PPAGC-1, TWIST PP
Manufacturer
Date Cleared
1997-07-23
(14 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
TRUTONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity: Moderate
Configuration: 1- TWIST PP AGC-1 1. High Frequency - Precipitously Sloping; TWIST PR. Flat
Other: TWIST PP AGC-1 1. Low tolerance To Loudness
Device Description
Not Found
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