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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K992638
Device Name DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631 -3800
Applicant Contact THOMAS ENGLISH
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631 -3800
Correspondent Contact THOMAS ENGLISH
Regulation Number870.2300
Classification Product Code
MWI  
Date Received08/06/1999
Decision Date 02/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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