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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K851931
Device Name DEFI 2
Applicant
S & W Medico Teknik
1819 H. St. NW
Federal Bar Bldg.
Washington,  DC  20006
Applicant Contact JES PETERSEN
Correspondent
S & W Medico Teknik
1819 H. St. NW
Federal Bar Bldg.
Washington,  DC  20006
Correspondent Contact JES PETERSEN
Regulation Number870.5300
Classification Product Code
LDD  
Date Received05/02/1985
Decision Date 08/05/1985
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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