K-number	K162332
Device name	Nexcore GI Insufflator
Applicant	Nexcore Technology, LLC
Product code	FCX
Device class	Class II
Decision date	Sep 29, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Nexcore GI Insufflator

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