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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flowmeter, blood, cardiovascular
510(k) Number K872048
Device Name TRANSONIC FLOWMETER
Applicant
TRANSONIC SYSTEMS, INC.
CORNELL RESEARCH PARK
138 LANGMUIR LABS
ITHACA,  NY  14850
Applicant Contact SHAWN P CREIGHTON
Correspondent
TRANSONIC SYSTEMS, INC.
CORNELL RESEARCH PARK
138 LANGMUIR LABS
ITHACA,  NY  14850
Correspondent Contact SHAWN P CREIGHTON
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/28/1987
Decision Date 06/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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