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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Manual
510(k) Number K924095
Device Name TIMEOSCOPE AND FLEXISCOPE
Applicant
Stethoscopes of America, Inc.
5300 Memorial Dr., Suite 216
Stone Mountain,  GA  30083
Applicant Contact JEROME MOORE
Correspondent
Stethoscopes of America, Inc.
5300 Memorial Dr., Suite 216
Stone Mountain,  GA  30083
Correspondent Contact JEROME MOORE
Regulation Number870.1875
Classification Product Code
LDE  
Date Received08/13/1992
Decision Date 10/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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