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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 K973222
Device Name SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 electronics ave.
danvers,  MA  01923
Original Contact jacqueline emery
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/21/1997
Decision Date 09/04/1997
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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