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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K943709
Device Name DINAMAP PLUS VITAL SIGNS MONOITOR
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact ANNETTE M HILLRING
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact ANNETTE M HILLRING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/01/1994
Decision Date 06/16/1995
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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