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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K962937
Device Name CARDIO TEAM II
Applicant
VISION ELECTRONICS
4 DAISY LN.
P.O. BOX 295
KIRKWOOD,  NY  13795
Applicant Contact SHAWN P WOOD
Correspondent
VISION ELECTRONICS
4 DAISY LN.
P.O. BOX 295
KIRKWOOD,  NY  13795
Correspondent Contact SHAWN P WOOD
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/29/1996
Decision Date 04/10/1997
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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