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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K991756
Device Name 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
Applicant
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Applicant Contact LONNIE WITHAM
Correspondent
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Correspondent Contact LONNIE WITHAM
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/24/1999
Decision Date 12/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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