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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 K122281
Device Name PADNET 2.0
Applicant
BIOMEDIX, INC.
178 East 9th Street
ST. PAUL,  MN  55101
Applicant Contact GREG HOCKING
Correspondent
BIOMEDIX, INC.
178 East 9th Street
ST. PAUL,  MN  55101
Correspondent Contact GREG HOCKING
Regulation Number870.2780
Classification Product Code
JOM  
Date Received07/30/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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