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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K100813
Device Name QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
Applicant
Pulse Biomedical, Inc.
1305 Catfish Ln.
Norristown,  PA  19403
Applicant Contact SALEEM HASAN
Correspondent
Pulse Biomedical, Inc.
1305 Catfish Ln.
Norristown,  PA  19403
Correspondent Contact SALEEM HASAN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/23/2010
Decision Date 07/23/2010
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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