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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 K061557
Device Name FUSION
Applicant
Medwave, Inc.
4382 Round Lake Rd. W.
Arden Hills,  MN  55112 -3923
Applicant Contact DONNA R LUNAK
Correspondent
Medwave, Inc.
4382 Round Lake Rd. W.
Arden Hills,  MN  55112 -3923
Correspondent Contact DONNA R LUNAK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/05/2006
Decision Date 09/15/2006
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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