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510(k) K011729

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 by Dni Nevada, Inc. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2001
Date Received
June 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type

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