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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Pacemaker
510(k) Number K863046
Device Name ULTRA SOFTWARE MODULE: MODEL 2016
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact ANN MORRISSEY
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact ANN MORRISSEY
Regulation Number870.3700
Classification Product Code
KRG  
Date Received08/12/1986
Decision Date 12/05/1986
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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