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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 K946333
Device Name IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER
Applicant
Irvine Biomedical, Inc.
2166 Michelson Dr.
Irvine,  CA  92715
Applicant Contact PETER CHEN
Correspondent
Irvine Biomedical, Inc.
2166 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact PETER CHEN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/29/1994
Decision Date 07/18/1995
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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