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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K852547
Device Name CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON
Applicant
Cortronic Corp.
260 Main St.
Northport,  NY  11768
Applicant Contact TED W RUSSELL
Correspondent
Cortronic Corp.
260 Main St.
Northport,  NY  11768
Correspondent Contact TED W RUSSELL
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/14/1985
Decision Date 11/10/1986
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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