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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 K081259
Device Name DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Applicant
Defibtech, LLC
741 Boston Post Rd.
Guilford,  CT  06437
Applicant Contact Ed Horton
Correspondent
Defibtech, LLC
741 Boston Post Rd.
Guilford,  CT  06437
Correspondent Contact Ed Horton
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/02/2008
Decision Date 06/15/2009
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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