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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 K844839
Device Name DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Applicant Contact MELANIE SABO
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Correspondent Contact MELANIE SABO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/12/1984
Decision Date 04/01/1985
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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