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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 K100531
Device Name VISCOPE, MODEL 100P,100S
Applicant
Hd Medical Services (India) Pvt.Ltd
11143 Twinleaf Way
San Diego,  CA  92131
Applicant Contact BILL MURPHY
Correspondent
Hd Medical Services (India) Pvt.Ltd
11143 Twinleaf Way
San Diego,  CA  92131
Correspondent Contact BILL MURPHY
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received02/24/2010
Decision Date 07/21/2010
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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