Name: Predicase
Price: 199 USD

K-number	K010130
Device name	POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
Applicant	Medtronic Functional Diagnostics A/S
Product code	FFX
Device class	Class II
Decision date	Feb 7, 2001
Decision	Substantially Equivalent
Regulation	876.1725

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Source

View the full FDA submission: accessdata.fda.gov

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POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

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