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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+
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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