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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K934692
Device Name K-DEFIB/PACE PEDIATRIC ELECTRODE
Applicant
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Applicant Contact LORNE SCHARNBERG
Correspondent
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Correspondent Contact LORNE SCHARNBERG
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/30/1993
Decision Date 01/24/1995
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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