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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 K912379
Device Name PDT CARRYALL TRANSMITTER, VARIOUS MODELS
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact CATHY YOHNK
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact CATHY YOHNK
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/29/1991
Decision Date 06/17/1991
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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