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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transport, patient, powered
510(k) Number K121561
Device Name FLOW2, SWING
Original Applicant
van utrechtweg 99
krimpen aan den ijssel
zuid-holland,  NL 2921 ln
Original Contact arnold heiden
Regulation Number890.5150
Classification Product Code
Date Received05/29/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No