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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K905831
Device Name ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
Applicant
Arzco Medical Electronics, Inc.
1029 Butterfield Rd.
(Duplicate/1927197)
Vernon Hills,  IL  60061
Applicant Contact RICHARD M BILOF
Correspondent
Arzco Medical Electronics, Inc.
1029 Butterfield Rd.
(Duplicate/1927197)
Vernon Hills,  IL  60061
Correspondent Contact RICHARD M BILOF
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/31/1990
Decision Date 03/29/1991
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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