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510(k) Data Aggregation
K Number
K993623Device Name
GEMINI E
Manufacturer
Date Cleared
2000-06-23
(241 days)
Product Code
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ALLEN MEDICAL INSTRUMENTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1) Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional.
2) Normal auscultation as above by a health care professional who wears hearing aids.
3) To allow four other listeners (e.g. students) to listen together with a health care professional.
Device Description
An electronic stethoscope utilizing conventional stethoscope components but amplifying auscultated sounds by means of a 3 volt electronic circuit. An output jack is provided for headphone use. The stethoscope is controlled by a single button which turns the unit on and adjusts the amplitude through four levels.
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