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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K011729
Device Name SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
Applicant
Dni Nevada, Inc.
2000 Arrowhead Dr.
Carson City,  NV  89706
Applicant Contact KRISTINE BOGGS
Correspondent
Dni Nevada, Inc.
2000 Arrowhead Dr.
Carson City,  NV  89706
Correspondent Contact KRISTINE BOGGS
Regulation Number870.3630
Classification Product Code
DTC  
Date Received06/04/2001
Decision Date 08/30/2001
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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