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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 K160016
Device Name Steth IO
Applicant
Stratoscientific, Inc.
1574 Northwest 190th St.
Shoreline,  WA  98177
Applicant Contact SUMAN MULUMUDI
Correspondent
Biomedical Devices Of Kansas
1205 E Us 24-40 Highway
Tonganoxie,  KS  66086
Correspondent Contact JIM WEST
Regulation Number870.1875
Classification Product Code
DQD  
Date Received01/05/2016
Decision Date 07/15/2016
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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