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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 K895916
Device Name PE INTERCARDIAC MAPPING SYSTEM (ICMS)
Applicant
Prucka Engineering, Inc.
4710 Bellaire Blvd. Suite 134
Bellaire,  TX  77401
Applicant Contact CHARLES J MORINA
Correspondent
Prucka Engineering, Inc.
4710 Bellaire Blvd. Suite 134
Bellaire,  TX  77401
Correspondent Contact CHARLES J MORINA
Regulation Number870.1220
Classification Product Code
DRF  
Date Received10/10/1989
Decision Date 12/13/1989
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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