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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
Model PADNET 2.0
Device Name PADNET 2.0
Original Applicant
178 east 9th street
st. paul,  MN  55101
Original Contact greg hocking
Regulation Number870.2780
Classification Product Code
Date Received07/30/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No