K-number	K162054
Device name	Medtronic Temporary External Pacemaker 53401
Applicant	Medtronic, Inc.
Product code	DTE
Device class	Class II
Decision date	Oct 18, 2016
Decision	Substantially Equivalent
Regulation	870.3600

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Source

View the full FDA submission: accessdata.fda.gov

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Medtronic Temporary External Pacemaker 53401

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