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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 K871436
Device Name PREDICTOR
Applicant
Corazonix Corp.
7700 N. Hudson, Suite 1
Oklahoma City,  OK  73116
Applicant Contact JAMES H LUBY
Correspondent
Corazonix Corp.
7700 N. Hudson, Suite 1
Oklahoma City,  OK  73116
Correspondent Contact JAMES H LUBY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/13/1987
Decision Date 06/19/1987
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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