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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 K915563
Device Name DIAGNOSTIC EP CATHETER
Applicant
Arrhythmia Technologies, Inc.
90 W. Plumeria Dr.
San Jose,  CA  95134
Applicant Contact GEORGE SAVAGE
Correspondent
Arrhythmia Technologies, Inc.
90 W. Plumeria Dr.
San Jose,  CA  95134
Correspondent Contact GEORGE SAVAGE
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/12/1991
Decision Date 03/09/1992
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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