Name: Predicase
Price: 199 USD

K-number	K061678
Device name	PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
Applicant	Prorhythm
Product code	DRF
Device class	Class II
Decision date	Jan 12, 2007
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25

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