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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K000500
Device Name DINAMAP ADVANCED NIBP MODULE
Applicant
Critikon Company, LLC
4502 Woodland Corporate Blvd.
Tampa,  FL  33614
Applicant Contact THOMAS J ENGLISH
Correspondent
Critikon Company, LLC
4502 Woodland Corporate Blvd.
Tampa,  FL  33614
Correspondent Contact THOMAS J ENGLISH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/14/2000
Decision Date 05/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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