Name: Predicase
Price: 199 USD

K-number	K022023
Device name	COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
Applicant	Clinical Innovations, Inc.
Product code	KLA
Device class	Class II
Decision date	Jan 7, 2003
Decision	Substantially Equivalent
Regulation	876.1725

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Source

View the full FDA submission: accessdata.fda.gov

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COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500

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