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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 K873624
Device Name KONTRON PULSE OXIMETER 7840
Applicant
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Applicant Contact DAVID CROMWICK
Correspondent
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Correspondent Contact DAVID CROMWICK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/08/1987
Decision Date 10/19/1988
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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