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510(k) Data Aggregation
K Number
K973376Device Name
LORI/LORI, LORI-S (LORI STOCK AID)
Manufacturer
Date Cleared
1997-10-14
(36 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
LORI MEDICAL LABORATORIES, INC.
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 anglify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(fes), (Check appropriate space(s)); Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat. Other: Low tolerance To Loudness.
Device Description
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K Number
K972058Device Name
LORIPRO, LORIPRO II
Manufacturer
Date Cleared
1997-08-15
(74 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
LORI MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conduction hearing alos in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(fes). (Check appropriate space(s)); Severity: X1. Slight X2. Mild X3. Moderate X4. Severe 5. Profound Configuration: X1. High Frequency - Precipitously Sloping X2. Gradually Sloping X3. Reverse Slope X4. Flat 5. Other Other X1. Low tolerance To Loudness X2. Normal Dynamic Range 3. ______
Device Description
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K Number
K964080Device Name
LORI HEARING AID SIMULATOR
Manufacturer
Date Cleared
1997-01-08
(89 days)
Product Code
Regulation Number
874.3330Why did this record match?
Applicant Name (Manufacturer) :
LORI MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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