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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K113865
Model BM-500/ BM-510
Device Name PULTOL
Original Applicant
1201 richardson drive
suite 280
richardson,  TX  75080
Original Contact diane rutherford
Regulation Number870.2700
Classification Product Code
Date Received12/30/2011
Decision Date 03/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No