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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 K900001
Device Name COROMETRICS MODEL 556 NEONATAL MONITOR
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 barnes park rd., north
wallingford,  CT  06492
Original Contact brian r barry
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/02/1990
Decision Date 11/29/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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