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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 K142709
Device Name samaritan PAD 450P
Applicant
Heartsine Technologies, Inc.
121 Friends Ln.
Suite 400
Newton,  PA  18940
Applicant Contact Paul Phillips
Correspondent
Regulatory Strategies, Inc.
808 E Fox Ln.
Fox Point,  WI  53217
Correspondent Contact Mark Kramer
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/22/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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