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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 K091972
Device Name MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
Applicant
Stethoscope Technologies, Inc.
38 Miller Ave. Pmb 170
Mill Valley,  CA  94941
Applicant Contact DAVID STARK
Correspondent
Stethoscope Technologies, Inc.
38 Miller Ave. Pmb 170
Mill Valley,  CA  94941
Correspondent Contact DAVID STARK
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/01/2009
Decision Date 09/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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