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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 K896919
Device Name HEARTSTART 3000
Applicant
Laerdal Medical Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Applicant Contact JOHN KARPOWICZ
Correspondent
Laerdal Medical Corp.
12244 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact JOHN KARPOWICZ
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/12/1989
Decision Date 05/03/1990
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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