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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 K010794
Device Name BRIDGE III RECEIVER
Applicant
MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST,  IE BT3 9ED
Applicant Contact RHONA LOVE
Correspondent
MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST,  IE BT3 9ED
Correspondent Contact RHONA LOVE
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/16/2001
Decision Date 05/10/2001
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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