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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K865035
Device Name RECORD KEEPING/DATA MANAGEMENT SYSTEM
Applicant
Critical Care Systems, Inc.
5000 Hollywood Blvd.
Hollywood,  FL  33021
Applicant Contact WENDY MARX
Correspondent
Critical Care Systems, Inc.
5000 Hollywood Blvd.
Hollywood,  FL  33021
Correspondent Contact WENDY MARX
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/23/1986
Decision Date 05/11/1987
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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