K-number	K011729
Device name	SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
Applicant	Dni Nevada, Inc.
Product code	DTC
Device class	Class II
Decision date	Aug 30, 2001
Decision	Substantially Equivalent
Regulation	870.3630

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View the full FDA submission: accessdata.fda.gov

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SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

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