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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 K990058
Device Name QMS MAPPING SYSTEM,MODEL 2000
Applicant
Cathdata, Inc.
1151 Hope St.
Stamford,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Cathdata, Inc.
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/07/1999
Decision Date 12/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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