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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 K940445
Device Name VIVALINK AED DEFIBRILLATOR
Applicant
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact BYRON GILMAN
Correspondent
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact BYRON GILMAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/01/1994
Decision Date 02/09/1995
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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