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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 K042799
Device Name QRS-CARD CARDIOLOGY SUITE
Applicant
Pulse Biomedical, Inc.
935 S. Trooper Rd.
Norristown,  PA  19403
Applicant Contact SALEEM HASAN
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/08/2004
Decision Date 10/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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