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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 K050228
Device Name AGFA HEARTLAB CARDIOVASCULAR
Applicant
HEARTLAB, INC.
1 CROSSWIND RD.
WESTERLY,  RI  02891
Applicant Contact RICHARD PETROCELLI
Correspondent
HEARTLAB, INC.
1 CROSSWIND RD.
WESTERLY,  RI  02891
Correspondent Contact RICHARD PETROCELLI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/01/2005
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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