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510(k) Data Aggregation
K Number
K973266Device Name
Z DEQ-II
Manufacturer
Date Cleared
1997-09-23
(25 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
ELECTONE, 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 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. Light
_2. Mild
_3. Moderate
_4. Severe
_5. Profound
Configuration:
✓1. High Frequency - Precipitously Sloping
✓2. Gradually Sloping
✓3. Reverse Slope
✓4. Flat
_5. Other Variable to 1-4
Other
✓1. Low tolerance To Loudness
_2.
_3.
Device Description
Not Found
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K Number
K961084Device Name
AM 400
Manufacturer
Date Cleared
1996-04-18
(30 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
ELECTONE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K955702Device Name
SONATA U-01
Manufacturer
Date Cleared
1996-02-22
(69 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
ELECTONE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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