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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 K991211
Device Name EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
Applicant
Reynolds Medical , Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford,  GB SG13 7NW
Applicant Contact GEORGE MYERS
Correspondent
Reynolds Medical , Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford,  GB SG13 7NW
Correspondent Contact GEORGE MYERS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/09/1999
Decision Date 07/08/1999
Decision Substantially Equivalent (SESE)
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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