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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 K012770
Device Name INFINITY MICRO2+
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 electronics ave.
danvers,  MA  01923
Original Contact penelope h greco
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/17/2001
Decision Date 07/23/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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