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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 K970368
Device Name SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 electronics ave.
danvers,  MA  01923
Original Contact jaqueline emery
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/31/1997
Decision Date 05/06/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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