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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, Programmable
510(k) Number K020127
Device Name SMARTFLOW PULSE TRANSMISSION COEFFICIENT
Applicant
Florence Medical , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact ORLY MAOR
Correspondent
Florence Medical , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact ORLY MAOR
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/15/2002
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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