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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 K121108
Model DA100PB, DA100P, DA100B, DA100
Device Name DOPPLEX ABILITY
Original Applicant
HUNTLEIGH HEALTHCARE
35 portmanmoor road
cardiff,  UK cf24 5hn
Original Contact david moynham
Regulation Number870.2780
Classification Product Code
JOM  
Date Received04/12/2012
Decision Date 01/03/2013
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
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