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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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