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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 K041772
Device Name DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
Applicant
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/01/2004
Decision Date 07/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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