K-number	K233357
Device name	EsoCool Thermal Regulation Catheter
Applicant	Nuvaira, Inc.
Product code	PLA
Device class	Class II
Decision date	Jun 27, 2024
Decision	Substantially Equivalent
Regulation	870.5910

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Source

View the full FDA submission: accessdata.fda.gov

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EsoCool Thermal Regulation Catheter

Everything you need for a 510(k) submission. Nothing you don't.