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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 K893470
Device Name SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE
Applicant
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact ROBERT R MURFITT
Correspondent
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact ROBERT R MURFITT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/04/1989
Decision Date 08/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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