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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 K904547
Device Name STETHOSCOPE
Applicant
Kimball Industries Co., Ltd.
C/O Health Pro Tech, Inc.
113 Robinwood Dr.
Shirley,  NY  11967
Applicant Contact ROSE DALEO
Correspondent
Kimball Industries Co., Ltd.
C/O Health Pro Tech, Inc.
113 Robinwood Dr.
Shirley,  NY  11967
Correspondent Contact ROSE DALEO
Regulation Number870.1875
Classification Product Code
LDE  
Date Received10/03/1990
Decision Date 03/21/1991
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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