Name: Predicase
Price: 199 USD

K-number	K222311
Device name	CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
Applicant	Circa Scientific, Inc.
Product code	FLL
Device class	Class II
Decision date	May 25, 2023
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

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