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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 K991007
Device Name K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
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 Received03/26/1999
Decision Date 08/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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