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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 K993608
Device Name DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
Applicant
Datex-Ohmeda, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/25/1999
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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