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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 K942842
Device Name HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE
Applicant
HEWLETT-PACKARD GMBH
MEDIZINELEKTRONIK
POSTFACH 1427
71004 BOBLINGEN,  DE
Applicant Contact EGON PFEIL
Correspondent
HEWLETT-PACKARD GMBH
MEDIZINELEKTRONIK
POSTFACH 1427
71004 BOBLINGEN,  DE
Correspondent Contact EGON PFEIL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/16/1994
Decision Date 02/16/1995
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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