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510(k) K863046

ULTRA SOFTWARE MODULE: MODEL 2016 by Cardiac Pacemakers, Inc. — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type

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