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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K073146
Device Name PADNET+
Applicant
Biomedix, Inc.
4215 White Bear Pkwy.
Suite 200
Vadnais Heights,  MN  55110
Applicant Contact WILLIAM ROGERS
Correspondent
Biomedix, Inc.
4215 White Bear Pkwy.
Suite 200
Vadnais Heights,  MN  55110
Correspondent Contact WILLIAM ROGERS
Regulation Number870.2780
Classification Product Code
JOM  
Subsequent Product Code
JAF  
Date Received11/08/2007
Decision Date 11/21/2007
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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