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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 K970481
Device Name V2
Applicant
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact SEW-WAY TAY
Correspondent
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact SEW-WAY TAY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received02/10/1997
Decision Date 07/01/1997
Decision SE SUBJECT TO TRACKING REG (ST)
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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