K-number	K211662
Device name	Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Applicant	Innovative Health, LLC
Product code	NLG
Device class	Class II
Decision date	Nov 18, 2021
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed IntellaMap Orion High Resolution Mapping Catheter

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