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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K013478
Device Name DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
Applicant
Pulse Metric, Inc.
11777 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact ROBERT DUFFY
Correspondent
Pulse Metric, Inc.
11777 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact ROBERT DUFFY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/19/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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