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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K031781
Device Name DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Applicant Contact JOEL KENT
Correspondent
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/10/2003
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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