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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, Physiological Signal, Radiofrequency
510(k) Number K964554
FOIA Releasable 510(k) K964554
Device Name PERSONAL TELEMEDICINE MODULE
Applicant
AMERICAN TELECARE, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact GERARD J PRUD`HOMME
Correspondent
AMERICAN TELECARE, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact GERARD J PRUD`HOMME
Regulation Number870.2910
Classification Product Code
DRG  
Date Received11/13/1996
Decision Date 12/17/1996
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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