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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 K915760
Device Name MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG
Applicant
Corazonic Corp.
4515 N. Santa Fe
Oklahoma City,  OK  73118
Applicant Contact JAMES H LUBY
Correspondent
Corazonic Corp.
4515 N. Santa Fe
Oklahoma City,  OK  73118
Correspondent Contact JAMES H LUBY
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/23/1991
Decision Date 02/14/1992
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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