Name: Predicase
Price: 199 USD

K-number	K112376
Device name	S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
Applicant	Circa Scientific, LLC
Product code	FLL
Device class	Class II
Decision date	Aug 31, 2011
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM

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