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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 K032230
Device Name RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
Applicant
Thinklabs, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Thinklabs, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/21/2003
Decision Date 11/26/2003
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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