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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K032531
Device Name CHASE CARDIAC ANALYSIS SYSTEM
Applicant
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Applicant Contact DAVID M HERNON
Correspondent
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Correspondent Contact DAVID M HERNON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/15/2003
Decision Date 02/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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