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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 K860854
Device Name CRITICALC
Applicant
Cygnus of South Florida, Inc.
560 NW 165th Rd.
Suite 309
Miami,  FL  33169
Applicant Contact ALAN SEGAL
Correspondent
Cygnus of South Florida, Inc.
560 NW 165th Rd.
Suite 309
Miami,  FL  33169
Correspondent Contact ALAN SEGAL
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/07/1986
Decision Date 12/08/1986
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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