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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K002742
Device Name SPHYGMOCOR MX MODEL SCOR-MX
Applicant
Pwv Medical Pty, Lt.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact KIRSTEN H PAULSON
Correspondent
Pwv Medical Pty, Lt.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact KIRSTEN H PAULSON
Regulation Number870.1110
Classification Product Code
DSK  
Date Received09/01/2000
Decision Date 05/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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