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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K134035
Device Name TRANSONIC HCM 103 SYSTEM
Applicant
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact NAVEEN THURAMALLA
Correspondent
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact NAVEEN THURAMALLA
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/31/2013
Decision Date 09/17/2014
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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