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510(k) Data Aggregation
K Number
K964680Device Name
COMFORTAID HEARING AID
Manufacturer
Date Cleared
1997-01-24
(63 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
ETHICAL HEARING INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
The design follows traditional principles of operation for Hearing Aids. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines.
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K Number
K962012Device Name
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
Manufacturer
Date Cleared
1996-08-21
(90 days)
Product Code
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
ETHICAL HEARING INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
Wizard Loudness Growth Tester
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