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Found 4 results
510(k) Data Aggregation
K Number
K972818Device Name
D72 DIGITAL
Manufacturer
Date Cleared
1997-10-17
(80 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEARING INSTRUMENTS CO.
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 some indicated for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated as and can and
Severity:
X 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.
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
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K Number
K971804Device Name
PHILIPS S1694, S1695
Manufacturer
Date Cleared
1997-06-06
(23 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEARING INSTRUMENTS CO.
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 The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)): Severity: 2. Mild, Configuration: 1. High Frequency - Precipitously Sloping, 3. Reverse Slope, 5. Other, Other: 1. Low tolerance To Loudness, 2., 3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.) 1., 2., 3.
Device Description
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K Number
K965088Device Name
M11 SERIES: M11, M11M
Manufacturer
Date Cleared
1997-01-24
(36 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEARING INSTRUMENTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961770Device Name
PHILIPS 71 SERIES
Manufacturer
Date Cleared
1996-08-02
(86 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS HEARING INSTRUMENTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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