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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 K002280
Device Name PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
Applicant
MEDICAL DEVICES, INC.
2500 BELL AVE.
DES MOINES,  IA  50321
Applicant Contact WARREN R WALTERS
Correspondent
MEDICAL DEVICES, INC.
2500 BELL AVE.
DES MOINES,  IA  50321
Correspondent Contact WARREN R WALTERS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/26/2000
Decision Date 02/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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