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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 K941763
Device Name ELECTRONIC-AMPLIFIED STETHOSCOPE
Applicant
Hsues' Brothers Medical, Inc.
499 Nibus St.
Suite D
Brea,  CA  92621
Applicant Contact ALFRED M WU
Correspondent
Hsues' Brothers Medical, Inc.
499 Nibus St.
Suite D
Brea,  CA  92621
Correspondent Contact ALFRED M WU
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/11/1994
Decision Date 09/06/1994
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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